Cleared Traditional

K130162 - LIQUID ASSAYED MULTIQUAL PREMIUM

K130162 is the FDA 510(k) clearance for LIQUID ASSAYED MULTIQUAL PREMIUM by Bio-Rad Laboratories. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K130162 · Bio-Rad Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
37d
Days
Class 1
Risk

K130162 is an FDA 510(k) clearance for the LIQUID ASSAYED MULTIQUAL PREMIUM. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 37 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 Laboratories devices

Submission Details

510(k) Number K130162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date March 01, 2013
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
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 369
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K130162.
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · Helena Laboratories · Oct 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963 · Bio-Rad Laboratories, Inc. · May 2013
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
K130761 · Bio-Rad Laboratories · Apr 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
K123775 · Bio-Rad Laboratories · Jan 2013
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · Bio-Rad Laboratories · Dec 2012
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603 · Randox Laboratories, Ltd. · Nov 2012