Cleared Traditional

K942853 - KOVA LIQUA-TROL

K942853 is an FDA 510(k) clearance for KOVA LIQUA-TROL, manufactured by Hycor Biomedical, Inc.. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K942853 · Hycor Biomedical, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
110d
Days
Class 1
Risk

K942853 is an FDA 510(k) clearance for the KOVA LIQUA-TROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hycor Biomedical, Inc. devices

FDA 510(k) Submission Details - K942853

510(k) Number K942853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1994
Decision Date October 04, 1994
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

JJW Device Classification - Class 1, General Controls

Product Code JJW Urinalysis Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJW Urinalysis Controls (assayed And Unassayed)

All 44
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K942853.
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451 · Medical Analysis Systems, Inc. · Sep 1997
QUANTIFY(901)
K972710 · Hematronix, Inc. · Aug 1997
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
K943780 · Heraeus Kulzer, Inc. · Oct 1994
MAS LIQUID URINALYSIS CONTROL
K935062 · Medical Analysis Systems, Inc. · Jan 1994
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467 · Heraeus Kulzer, Inc. · May 1993
BIOTROL CHEMISTRY URINE CONTROL
K891286 · Biotrol, USA, Inc. · Apr 1989