Cleared Traditional

K040822 - LIQUICHEK TORCH PLUS IGM CONTROL

K040822 is the FDA 510(k) clearance for LIQUICHEK TORCH PLUS IGM CONTROL by Bio-Rad Laboratories, Inc.. It is a Class 1 Microbiology device (product code JJY) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K040822 · Bio-Rad Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
50d
Days
Class 1
Risk

K040822 is an FDA 510(k) clearance for the LIQUICHEK TORCH PLUS IGM CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on May 19, 2004 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology device 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 Laboratories, Inc. devices

Submission Details

510(k) Number K040822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2004
Decision Date May 19, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 102d · This submission: 50d
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 342
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K040822.
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