Cleared Traditional

UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) (K872303) - FDA 510(k) Clearance

Class I Chemistry device.

K872303 · Vanguard Diagnostic Systems · Chemistry device
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Jul 1987
Decision
22d
Days
Class 1
Risk

K872303 is an FDA 510(k) clearance for the UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Vanguard Diagnostic Systems (La Habra, US). The FDA issued a Cleared decision on July 7, 1987 after a review of 22 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vanguard Diagnostic Systems devices

Submission Details

510(k) Number K872303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date July 07, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 167
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K872303.
LYPHOCHEK WHOLE BLOOD CONTROL
K874731 · Bio-Rad · Feb 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · Bio-Rad · Jan 1988
PRECINORM L
K874230 · Boehringer Mannheim Corp. · Nov 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227 · Bio-Rad · Jul 1987
MULTI-ANALYTE LIN-TROL
K863751 · Sigma Diagnostics, Inc. · Nov 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986