Cleared Traditional

K945083 - ACCESS CK-MB REAGENTS

K945083 is the FDA 510(k) clearance for ACCESS CK-MB REAGENTS by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K945083 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
35d
Days
Class 2
Risk

K945083 is an FDA 510(k) clearance for the ACCESS CK-MB REAGENTS. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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, Inc. devices

Submission Details

510(k) Number K945083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1994
Decision Date November 21, 1994
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 16
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K945083.
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
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ACS CKMB II IMMUNOASSAY
K962126 · Ciba Corning Diagnostics Corp. · Jun 1996
ROCHE ISOMUNE- CK
K903025 · Roche Diagnostic Systems, Inc. · Aug 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806 · Baxter Healthcare Corp · Mar 1990
UNI-FAST CREATINE KINASE TEST (CK)
K872029 · Sclavo, Inc. · Jun 1987