Cleared Traditional

K002196 - LYPHOCHEK FERTILITY CONTROL

K002196 is the FDA 510(k) clearance for LYPHOCHEK FERTILITY CONTROL by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K002196 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
18d
Days
Class 1
Risk

K002196 is an FDA 510(k) clearance for the LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483. 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 August 7, 2000 after a review of 18 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 K002196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date August 07, 2000
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 K002196.
N/T PROTEIN CONTROL SL
K002852 · Dade Behring, Inc. · Nov 2000
SYNCHRON CONTROL
K003488 · Beckman Coulter, Inc. · Nov 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
K002460 · Bio-Rad · Aug 2000
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
K001758 · Medical Analysis Systems, Inc. · Jul 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · Bio-Rad · May 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875 · Bio-Rad · Apr 2000