| Device Type ID | 470 |
| Device Name | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 470 |
| Device | Multi-analyte Controls, All Kinds (assayed) |
| Product Code | JJY |
| 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 | 2 | |
Bio-Rad Laboratories | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
HORIBA ABX SAS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAINE STANDARDS COMPANY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RANDOX LABORATORIES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 23 |
Human-Device Interface Problem | 4 |
Device Handling Problem | 2 |
Human Factors Issue | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
False Positive Result | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Difficult To Open Or Close | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 35 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alere San Diego, Inc. | II | Nov-16-2016 |
| 2 | Alere San Diego, Inc. | III | Oct-15-2015 |
| 3 | Horiba Instruments, Inc Dba Horiba Medical | III | Feb-03-2014 |
| 4 | Horiba Instruments, Inc Dba Horiba Medical | II | Jan-31-2014 |
| 5 | Medtest Holdings, Inc. | III | Jun-08-2017 |
| 6 | Medtest Holdings, Inc. | III | May-20-2017 |
| 7 | MedtestDx, Inc. | II | Sep-15-2015 |
| 8 | Microgenics Corporation | II | Dec-04-2014 |
| 9 | Microgenics Corporation | III | Jun-26-2014 |
| 10 | Ortho Clinical Diagnostics Inc | III | Mar-01-2018 |
| 11 | Randox Laboratories | III | Mar-12-2018 |
| 12 | Randox Laboratories | III | May-26-2017 |
| 13 | Randox Laboratories | II | Dec-14-2016 |
| 14 | Randox Laboratories Ltd. | II | Mar-26-2019 |
| 15 | Randox Laboratories Ltd. | II | Nov-03-2018 |
| 16 | Randox Laboratories Ltd. | II | Jul-30-2018 |
| 17 | Randox Laboratories Ltd. | II | Jun-13-2018 |
| 18 | Randox Laboratories, Limited | II | Mar-09-2018 |
| 19 | Roche Diagnostics Corporation | II | May-31-2017 |
| 20 | Siemens Healthcare Diagnostics, Inc. | II | Nov-16-2016 |
| 21 | Siemens Healthcare Diagnostics, Inc. | III | Nov-13-2014 |
| 22 | Tosoh Bioscience Inc | II | May-14-2018 |