Cleared Traditional

K874731 - LYPHOCHEK WHOLE BLOOD CONTROL

K874731 is the FDA 510(k) clearance for LYPHOCHEK WHOLE BLOOD CONTROL by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K874731 · Bio-Rad · Chemistry device
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Feb 1988
Decision
92d
Days
Class 1
Risk

K874731 is an FDA 510(k) clearance for the LYPHOCHEK WHOLE BLOOD CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 92 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 Bio-Rad devices

Submission Details

510(k) Number K874731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date February 18, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 464
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K874731.
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II
K881275 · Fisher Scientific Co., LLC · May 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494 · Bio-Rad · Mar 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175 · Baxter Healthcare Corp · Mar 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · Bio-Rad · Jan 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · Biotrol, USA, Inc. · Jan 1988
DC-TROL LEVEL 1 OR 2
K874772 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1988