| Device Type ID | 469 |
| Device Name | Single (specified) Analyte Controls (assayed And Unassayed) |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| 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 | 862.1660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JJX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 469 |
| Device | Single (specified) Analyte Controls (assayed And Unassayed) |
| Product Code | JJX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| CFR Regulation Number | 862.1660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AALTO SCIENTIFIC LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAYER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAYER HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMMUNODIAGNOSTIC SYSTEMS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MAINE STANDARDS COMPANY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUANTIMETRIX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
TOSOH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 51 |
Output Problem | 6 |
Device Operates Differently Than Expected | 6 |
High Readings | 6 |
Device Operational Issue | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Low Test Results | 3 |
Use Of Incorrect Control Settings | 1 |
Wireless Communication Problem | 1 |
Incorrect Or Inadequate Test Results | 1 |
Defective Device | 1 |
Display Or Visual Feedback Problem | 1 |
Device Expiration Issue | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Low Readings | 1 |
Data Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
High Test Results | 1 |
Physical Property Issue | 1 |
| Total Device Problems | 93 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | Oct-24-2014 |
| 2 | Abbott Laboratories | II | May-29-2014 |
| 3 | Bayer Healthcare, LLC | II | Aug-29-2015 |
| 4 | Beckman Coulter Inc. | II | Nov-15-2016 |
| 5 | Bio-Rad Laboratories, Inc. | III | Jun-25-2015 |
| 6 | Biochemical Diagnostics Inc | III | Nov-23-2015 |
| 7 | Helena Laboratories, Inc. | III | Nov-30-2018 |
| 8 | Randox Laboratories Ltd. | II | Mar-15-2019 |
| 9 | Siemens Healthcare Diagnostics, Inc | II | Feb-25-2017 |