Cleared Traditional

K882542 - LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (...

K882542 is the FDA 510(k) clearance for LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (... by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K882542 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
30d
Days
Class 1
Risk

K882542 is an FDA 510(k) clearance for the LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II. 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 July 21, 1988 after a review of 30 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 K882542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date July 21, 1988
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 468
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K882542.
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728 · Amersham Corp. · Oct 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124 · Amersham Corp. · Sep 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727 · Amersham Corp. · Aug 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · Baxter Healthcare Corp · Jul 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · Hichem Diagnostics · Jul 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · Hichem Diagnostics · Jul 1988