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.
Cleared Devices (61)
| 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 |
| K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 | Medical Analysis Systems, Inc. | Jun 29, 1998 | SESE |
| K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 | Medical Analysis Systems, Inc. | Sep 29, 1997 | SESE |
| K972710 | QUANTIFY(901) | Hematronix, Inc. | Aug 15, 1997 | SESE |
| K952840 | KENLOR LIQUID TOTAL URINE CONTROL | Kenlor Industries, Inc. | Jul 19, 1995 | SESE |
| K945913 | IRISPEC URINE CHEMISTRY CONTROL PART A AND B | International Remote Imaging Systems | Apr 5, 1995 | SESE |
| K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) | Heraeus Kulzer, Inc. | Oct 31, 1994 | SESE |
| K942853 | KOVA LIQUA-TROL | Hycor Biomedical, Inc. | Oct 4, 1994 | SESE |
| K935062 | MAS LIQUID URINALYSIS CONTROL | Medical Analysis Systems, Inc. | Jan 27, 1994 | SESE |
| K934257 | U-TROL LIQUID URINE DIPSTICK CONTROL | P.T. Meditrol | Nov 26, 1993 | SESE |
| K931467 | CHEK-STIX CONTROL STRIPS FOR URINALYSIS | Heraeus Kulzer, Inc. | May 11, 1993 | SESE |
| K902699 | SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) | Actio, Inc. | Jul 16, 1990 | SESE |
| K891286 | BIOTROL CHEMISTRY URINE CONTROL | Biotrol, USA, Inc. | Apr 10, 1989 | SESE |
| K890577 | KENLOR LIQUID URINE CONTROL | Kenlor Industries, Inc. | Mar 9, 1989 | SESE |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | Fisher Scientific Co., LLC | Mar 8, 1989 | SESE |
| K884424 | LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) | Bio-Rad | Dec 15, 1988 | SESE |
| K880496 | LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) | Bio-Rad | Mar 16, 1988 | SESE |
| K880495 | LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) | Bio-Rad | Mar 15, 1988 | SESE |
| K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL | Quantimetrix Medical Industries | Jan 21, 1988 | SESE |
| K863127 | TESTPACK ACUTE HCG URINGE CONTROLS | Abbott Laboratories | Sep 15, 1986 | SESE |
| K861756 | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II | Texas Immunology, Inc. | Jul 7, 1986 | SESE |
| K853603 | CANTROL URINE DIPSTICK CONTROL TWO LEVELS | Canyon Diagnostics, Inc. | Oct 8, 1985 | SESE |
| K852295 | UROL-GUANT | Dimension Diagnostics | Jul 22, 1985 | SESE |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | Icl Scientific | Oct 5, 1984 | SESE |
| K842366 | OXALATE URINE CONTROLS NORMAL & ELEVAT | Sigma Chemical Co. | Sep 12, 1984 | SESE |
| K840848 | BIOSURE | Helena Laboratories | May 1, 1984 | SESE |
| K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS | Biodiagnostic Intl | Apr 4, 1984 | SESE |
| K832713 | IRI SPEC URINALYSIS CONTROL | Intl. Remote Imaging Systems | Dec 22, 1983 | SESE |
| K831526 | URINE TOTAL PROTEIN CONTROL | Quantimetrix Corp. | Aug 12, 1983 | SESE |
| K831994 | BIOCHECK POSITIVE URINE CONTROL | Helena Laboratories | Aug 8, 1983 | SESE |
| K830834 | NEGATIVE URINE CONTROL | Helena Laboratories | Apr 12, 1983 | SESE |
| K822540 | COUNT-10 TROL | Texas Immunology, Inc. | Oct 8, 1982 | SESE |
| K810917 | KOVA TROL I HUMAN URINE (DRIED) | Icl Scientific | Apr 14, 1981 | SESE |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | Environmental Chemical Specialties | Dec 6, 1979 | SESE |
| K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) | Environmental Chemical Specialties | Dec 6, 1979 | SESE |
| K781961 | CONTROL STRIP FOR VISUAL URINALYSIS | Miles Laboratories, Inc. | Feb 8, 1979 | SESE |
| K781691 | CHEMSTRIP CONTROL | Boehringer Mannheim Corp. | Dec 20, 1978 | SESE |
| K780802 | ARMTROL AND FERMTROL | Biotron , Ltd. | Jun 13, 1978 | SESE |
| K780482 | KOVA TROL III | Icl Scientific | May 3, 1978 | SESE |
| K771713 | TEK-CHEK-2 | Miles Laboratories, Inc. | Oct 18, 1977 | SESE |
| K770390 | URINALYSIS PROFICIENCY | Miles Laboratories, Inc. | May 3, 1977 | SESE |
| K760863 | PRODUCT #K3002 KETOTROL-N(URINE CONTROL) | Sigma Chemical Co. | Nov 2, 1976 | SESE |
Top Applicants
- Medical Analysis Systems, Inc. — 6 clearances
- Bio-Rad — 5 clearances
- Miles Laboratories, Inc. — 3 clearances
- Icl Scientific — 3 clearances
- Helena Laboratories — 3 clearances
