Calculator/data Processing Module, For Clinical Use

Device Code: 564

Product Code(s): JQP

Device Classification Information

Device Type ID	564
Device Name	Calculator/data Processing Module, For Clinical Use
Regulation Description	Calculator/data Processing Module For Clinical Use.
Regulation Medical Specialty	Clinical Chemistry
Review Panel	Clinical Chemistry
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(K) Exempt
CFR Regulation Number	862.2100 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	JQP
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

13-9 CLSI AUTO2-A2
Laboratory Automation: Bar Codes For Specimen Container Identification
13-12 CLSI AUTO4-A
Laboratory Automation: Systems Operational Requirements, Characteristics, And Information Elements; Approved Standard
13-13 CLSI AUTO5-A
Laboratory Automation: Electromechanical Interfaces; Approved Standard
13-14 CLSI POCT1-A2
Point-of-Care Connectivity
13-15 CLSI AUTO13-A2 (Formerly GP19-A2)
Laboratory Instruments And Data Management Systems: Design Of Software User Interfaces And End-User Software Systems Validation, Operation, And Monitoring; Approved Guideline - Second Edition
13-17 CLSI LIS02-A2
Standard Specification For Transferring Information Between Clinical Instruments And Computer Systems; Approved Standard-Second Edition
13-18 CLSI LIS03-A
Standard Guide For Selection Of A Clinical Laboratory Information Management System
13-19 CLSI LIS04-A
Standard Guide For Documentation Of Clinical Laboratory Computer Systems
13-20 CLSI LIS05-A
Standand Specification For Transferring Clinical Observations Between Independent Computer Systems
13-21 CLSI LIS06-A
Standard Practice For Reporting Reliability Of Clinical Laboratory Information Systems
13-22 CLSI LIS07-A
Standard Specification For Use Of Bar Codes On Specimen Tubes In The Clinical Laboratory
13-23 CLSI LIS08-A
Standard Guide For Functional Requirements Of Clinical Laboratory Information Management Systems
13-24 CLSI LIS09-A
Standard Guide For Coordination Of Clinical Laboratory Services Within The Electronic Health Record Environment And Networked Architectures
13-25 CLSI AUTO8-A
Managing And Validating Laboratory Information Systems; Approved Guideline
13-26 CLSI AUTO10-A
Autoverification Of Clinical Laboratory Test Results; Approved Guideline
13-28 CLSI AUTO9-A
Remote Access To Clinical Laboratory Diagnostic Devices Via The Internet; Approved Standard
13-29 CLSI LIS01-A2
Standard Specification For Low-Level Protocol To Transfer Messages Between Clinical Laboratory Instruments And Computer Systems
13-30 CLSI AUTO3-A2
Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, And Information Systems; Approved Standard
13-37 CLSI AUTO7-A
Laboratory Automation: Data Content For Specimen Identification; Approved Standard
13-68 ISO 11073-90101 First Edition 2008-01-15
Health Informatics - Point-of-care Medical Device Communication - Part 90101: Analytical Instruments -- Point-of-care Test
13-85 CLSI AUTO11-A2
Information Technology Security Of In Vitro Diagnostic Instruments And Software Systems; Approved Standard - Second Edition

Total Product Life Cycle

Device Type ID	564
Device	Calculator/data Processing Module, For Clinical Use
Product Code	JQP
FDA Device Classification	Class 1 Medical Device
Regulation Description	Calculator/data Processing Module For Clinical Use.
CFR Regulation Number	862.2100 [🔎]

Device Problems
Missing Information	187
Use Of Device Problem	65
Output Problem	51
Adverse Event Without Identified Device Or Use Problem	45
Device Operational Issue	40
Computer Software Problem	37
Patient Data Problem	37
Problem With Software Installation	33
High Test Results	28
Incorrect, Inadequate Or Imprecise Result Or Readings	28
Charred	22
Data Problem	20
Incorrect Or Inadequate Test Results	13
Thermal Decomposition Of Device	13
Device Issue	13
Application Program Problem	13
Low Test Results	11
Mechanical Problem	10
Melted	10
Smoking	9
Device Operates Differently Than Expected	9
Programming Issue	8
Improper Or Incorrect Procedure Or Method	8
Loss Of Data	7
Electrical /Electronic Property Problem	7
Non Reproducible Results	6
Electrical Shorting	6
Device Subassembly	6
Human Factors Issue	6
False Negative Result	6
Device Handling Problem	5
Device Inoperable	5
Incorrect Software Programming Calculations	5
Insufficient Information	4
Unintended Movement	3
Fuse	3
Fail-Safe Problem	3
Syringe	3
Fire	2
Defective Component	2
Power Cord	2
Use Of Incorrect Control Settings	2
Installation-Related Problem	2
Missing Value Reason	2
Overheating Of Device	2
No Device Output	1
Positioning Problem	1
Scratched Material	1
Connector	1
Sensor	1
Interface	1
Mechanical Jam	1
Operating System Version Or Upgrade Problem	1
Tube	1
Device Emits Odor	1
Excessive Heating	1
Monitor	1
Fail-Safe Design Failure	1
Material Integrity Problem	1
Mechanism	1
Valve	1
Frame	1
Power Module	1
Rectifier	1
Application Program Problem: Parameter Calculation Error	1
Cable	1
PC (Printed Circuit) Board	1
Transformer	1
Visual Prompts Will Not Clear	1
Date/Time-Related Software Problem	1
Sparking	1
Implant Mobility NOS (Not Otherwise Specified)	1
Application Program Version Or Upgrade Problem	1
Communication Or Transmission Problem	1
Device Component Or Accessory	1
Application Program Problem: Dose Calculation Error	1
Switches	1
Capacitor	1
Connection Problem	1
No Apparent Adverse Event	1
Appropriate Term/Code Not Available	1
Processor	1
Total Device Problems	836

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Point Of Care Inc.	II	Mar-08-2018
2	Beckman Coulter Inc	II	Jun-25-2015
3	Beckman Coulter Inc.	III	Oct-31-2018
4	Beckman Coulter Inc.	II	Mar-22-2018
5	Beckman Coulter Inc.	II	Mar-21-2018
6	Beckman Coulter Inc.	III	Jan-18-2017
7	Becton Dickinson & Co.	II	Mar-23-2019
8	Becton Dickinson & Co.	II	Feb-27-2017
9	Data Innovations, LLC	II	Oct-22-2018
10	Data Innovations, LLC	II	Feb-16-2017
11	Data Innovations, LLC	II	Sep-12-2014
12	GE Healthcare It	II	Aug-26-2016
13	GE Healthcare It	III	Jan-29-2014
14	GE Healthcare It	II	Jan-02-2014
15	Ge Healthcare It	III	Jun-26-2015
16	Horiba Instruments, Inc Dba Horiba Medical	II	Mar-11-2014
17	Inpeco S.A.	II	Oct-31-2018
18	Inpeco S.A.	II	May-10-2018
19	McKesson Technologies, Inc.	II	Jul-27-2015
20	Medical Information Technology, Inc.	II	Mar-19-2014
21	Medical Information Technology, Inc.	II	Mar-03-2014
22	Merge Healthcare, Inc.	II	May-25-2017
23	Merge Healthcare, Inc.	II	Nov-11-2016
24	Normand Informatique	II	Dec-13-2017
25	Perkin Elmer Life Sciences Inc	II	Oct-26-2015
26	PerkinElmer Health Sciences, Inc.	II	Dec-23-2016
27	PerkinElmer Health Sciences, Inc.	II	Aug-07-2014
28	PerkinElmer Life And Analytical Sciences, Wallac, OY	II	Apr-27-2018
29	PerkinElmer Life And Analytical Sciences, Wallac, OY	II	Mar-13-2017
30	Radiometer America Inc	II	Sep-06-2014
31	Roche Diabetes Care, Inc.	II	Apr-02-2015
32	Roche Diagnostics Corporation	II	Aug-27-2018
33	Roche Diagnostics Corporation	II	Jun-02-2017
34	Roche Diagnostics Corporation	II	Mar-23-2017
35	Roche Diagnostics Corporation	II	Jan-24-2017
36	Roche Diagnostics Operations, Inc.	II	Oct-25-2016
37	Roche Diagnostics Operations, Inc.	II	Mar-23-2016
38	Roche Diagnostics Operations, Inc.	II	Nov-18-2015
39	Roche Diagnostics Operations, Inc.	II	Sep-01-2014
40	SCC Soft Computer	II	Feb-09-2015
41	SCC Soft Computer	II	Feb-02-2015
42	SCC Soft Computer	II	May-09-2014
43	Siemens Healthcare Diagnostics Inc	III	Jul-17-2014
44	Siemens Healthcare Diagnostics, Inc.	II	Feb-15-2017
45	Siemens Healthcare Diagnostics, Inc.	II	Jul-02-2015
46	Siemens Healthcare Diagnostics, Inc.	II	Jun-30-2015
47	Siemens Healthcare Diagnostics, Inc.	II	Jan-15-2015
48	Siemens Healthcare Diagnostics, Inc.	II	Sep-01-2014
49	Siemens Healthcare Diagnostics, Inc.	II	Jun-30-2014
50	Siemens Healthcare Diagnostics, Inc.	II	Jan-24-2014
51	Technidata S.A.	III	Mar-31-2014
52	bioMerieux, Inc.	II	Dec-16-2015

TPLC Last Update: 2019-04-02 19:36:33