Cleared Traditional

KOVA LIQUA-TROL (K942853) - FDA 510(k) Clearance

Class I Chemistry device.

K942853 · Hycor Biomedical, Inc. · Chemistry device
Download Printable Device Report (PDF)
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

Submission Details

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
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 60
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K942853.
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
K031231 · Bio-Rad · Jun 2003
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · Bio-Rad · Apr 2000
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · Bio-Rad · Dec 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
K880496 · Bio-Rad · Mar 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495 · Bio-Rad · Mar 1988
TESTPACK ACUTE HCG URINGE CONTROLS
K863127 · Abbott Laboratories · Sep 1986