JJW · Urinalysis Controls (Assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJW |
|---|---|
| Device Name | Urinalysis Controls (Assayed And Unassayed) |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170091 | UA-Cellular Complete | Streck | Feb 9, 2017 | SESE |
| K142262 | AUTION CHECK PLUS | Quantimetrix Corp. | Apr 10, 2015 | SESE |
| K131444 | UA-CELLULAR COMPLETE | Streck | Jan 29, 2014 | SESE |
| K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | Randox Laboratories Limited | Sep 30, 2011 | SESE |
| K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | ACON Laboratories, Inc. | Feb 2, 2011 | SESE |
| K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | Cliniqa Corporation | Jan 16, 2009 | SESE |
| K072640 | IRISPEC,CA/CB/CC | Iris Diagnostics | Dec 21, 2007 | SESE |
| K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X | Bio-Rad, Diagnostics Grp. | Apr 25, 2007 | SESE |
| K052242 | ADVIA CHEMISTRY MICROALBUMIN CONTROLS | Bayer Healthcare, LLC | Oct 3, 2005 | SESE |
| K043266 | RANDOX URINE CONTROLS | Randox Laboratories, Ltd. | Feb 15, 2005 | SESE |
| K042446 | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS | Bio-Rad Laboratories, Inc. | Nov 2, 2004 | SESE |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | Medical Analysis Systems, Inc. | Jul 1, 2003 | SESE |
| K031231 | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS | Bio-Rad | Jun 18, 2003 | SESE |
| K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL | Medical Analysis Systems, Inc. | Dec 11, 2002 | SESE |
| K022085 | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL | J & S Medical Assoc., Inc. | Jul 25, 2002 | SESE |
| K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL | Medical Analysis Systems, Inc. | Apr 29, 2002 | SESE |
| K000874 | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 | Bio-Rad | Apr 18, 2000 | SESE |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Consolidated Technologies, Inc. | Sep 3, 1999 | SESE |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Consolidated Technologies, Inc. | Sep 3, 1999 | SESE |
| K991917 | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET | Metrika, Inc. | Jul 12, 1999 | SESE |
Top Applicants
- Medical Analysis Systems, Inc. — 6 clearances
- Bio-Rad — 5 clearances
- Helena Laboratories — 3 clearances
- Icl Scientific — 3 clearances
- Miles Laboratories, Inc. — 3 clearances
