Cleared Traditional

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961412 · Bayer Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
67d
Days
Class 2
Risk

K961412 is an FDA 510(k) clearance for the CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 18, 1996 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1215 - the FDA toxicology 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 Bayer Corp. devices

Submission Details

510(k) Number K961412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1996
Decision Date June 18, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHY Colorimetric 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 Toxicology devices follow this clearance model.

Regulatory Peers - JHY Colorimetric Method, Cpk Or Isoenzymes

All 39
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K961412.
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories · Oct 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · Roche Diagnostics Corp. · Aug 2002
ELECSYS CK-MB STAT
K974421 · Boehringer Mannheim Corp. · Dec 1997
IMX(R) STAT CK-MB
K931172 · Abbott Laboratories · Jun 1993
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
COBAS READY CK REAGENT
K896240 · Roche Diagnostic Systems, Inc. · Feb 1990