Cleared Traditional

K925151 - LIQUICHEK CK-MB CONTROL LEVELS 1

K925151 is the FDA 510(k) clearance for LIQUICHEK CK-MB CONTROL LEVELS 1 by Bio-Rad. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K925151 · Bio-Rad · Chemistry device
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Dec 1992
Decision
65d
Days
Class 1
Risk

K925151 is an FDA 510(k) clearance for the LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 65 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 K925151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date December 17, 1992
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
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 - JJT Enzyme Controls (assayed And Unassayed)

All 58
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K925151.
HICHEM ENZYME VERIFIER KIT
K943684 · Hi Chem, Inc. · Oct 1994
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
K932442 · Helena Laboratories · Oct 1993
ROCHE CARDIOTROL-CK
K930889 · Roche Diagnostic Systems, Inc. · Jul 1993
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · Bio-Rad · Aug 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · Hichem Diagnostics · Jun 1990
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989