Radioimmunoassay, Thyroid-stimulating Hormone

Device Code: 505

Product Code(s): JLW

Device Classification Information

Device Type ID505
Device NameRadioimmunoassay, Thyroid-stimulating Hormone
Regulation DescriptionThyroid Stimulating Hormone Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1690 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJLW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID505
DeviceRadioimmunoassay, Thyroid-stimulating Hormone
Product CodeJLW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionThyroid Stimulating Hormone Test System.
CFR Regulation Number862.1690 [🔎]
Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
 
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
 
SUBSTANTIALLY EQUIVALENT
1
BODITECH MED INC.
 
SUBSTANTIALLY EQUIVALENT
1
NANOEN TEK USA, INC.
 
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS CORP.
 
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS OPERATIONS, INC
 
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD
 
SUBSTANTIALLY EQUIVALENT
1
SIEMENS
 
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
 
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
 
SUBSTANTIALLY EQUIVALENT
1
SYSMEX
 
SUBSTANTIALLY EQUIVALENT
1
SYSMEX CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Low Test Results
251
High Test Results
227
Incorrect Or Inadequate Test Results
117
Adverse Event Without Identified Device Or Use Problem
27
Non Reproducible Results
14
Unable To Obtain Readings
11
Device Damaged Prior To Use
11
Incorrect, Inadequate Or Imprecise Result Or Readings
5
Cell
4
Tube
3
Probe
3
High Readings
3
No Apparent Adverse Event
2
Appropriate Term/Code Not Available
2
Mechanical Problem
2
Insufficient Information
1
Clamp
1
Device Issue
1
Device Contamination With Chemical Or Other Material
1
Low Readings
1
False Positive Result
1
Device Operational Issue
1
Device Ingredient Or Reagent
1
Total Device Problems 690
Recalls
Manufacturer Recall Class Date Posted
1
Abbott Ireland Diagnostics Division
II Dec-22-2018
2
Clinical Diagnostic Systems
III Apr-10-2018
3
Nichols Institute Diagnostics
II Jun-25-2015
4
ORTHO-CLINICAL DIAGNOSTICS
III Aug-17-2016
5
Ortho Clinical Diagnostics Inc
II Oct-03-2018
6
Ortho-Clinical Diagnostics
II Oct-05-2018
7
Siemens Healthcare Diagnostics, Inc
II May-23-2014
8
Siemens Healthcare Diagnostics, Inc.
II Jun-01-2018
9
Siemens Healthcare Diagnostics, Inc.
II May-04-2018
10
Siemens Healthcare Diagnostics, Inc.
II May-05-2017
11
Siemens Healthcare Diagnostics, Inc.
II Oct-12-2016
12
Siemens Healthcare Diagnostics, Inc.
II Jul-21-2016
13
Siemens Healthcare Diagnostics, Inc.
II Jun-04-2015
14
Tosoh Bioscience Inc
II Jun-05-2018
TPLC Last Update: 2019-04-02 19:35:45

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