Cleared Traditional

K992172 - LYPHOCHEK TUMOR MARKER CONTROL

K992172 is the FDA 510(k) clearance for LYPHOCHEK TUMOR MARKER CONTROL by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992172 · Bio-Rad · Chemistry device

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Sep 1999

Decision

66d

Days

Class 1

Risk

K992172 is an FDA 510(k) clearance for the LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on September 2, 1999 after a review of 66 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 Bio-Rad devices

Submission Details

510(k) Number	K992172 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 28, 1999
Decision Date	September 02, 1999
Days to Decision	66 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 faster than avg

Panel avg: 88d · This submission: 66d

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 463

Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K992172.

PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA

K992900 · Roche Diagnostics Corp. · Nov 1999

PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

K993360 · Roche Diagnostics Corp. · Nov 1999

LYPHOCHEK ANEMIA CONTROL, MODEL 500

K992741 · Bio-Rad · Nov 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS

K992349 · Ortho-Clinical Diagnostics, Inc. · Aug 1999

LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3

K992550 · Bio-Rad · Aug 1999

N/T PROTEIN CONTROL LC

K991704 · Dade Behring, Inc. · Jun 1999

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K992172

Bio-Rad

Irvine, CA · US

ELIZABETH PLATT

Regulatory profile

319 submissions 319 cleared

100% clearance rate · Active in Chemistry

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