Cleared Traditional

K931172 - IMX STAT CK-MB

K931172 is an FDA 510(k) clearance for IMX STAT CK-MB, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JHY cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K931172 · Abbott Laboratories · Chemistry device
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Jun 1993
Decision
99d
Days
Class 2
Risk

K931172 is an FDA 510(k) clearance for the IMX(R) STAT CK-MB. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K931172

510(k) Number K931172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date June 15, 1993
Days to Decision 99 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
11d slower than avg
Panel avg: 88d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHY Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - JHY Colorimetric Method, Cpk Or Isoenzymes

All 33
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K931172.
ELECSYS CK-MB STAT
K974421 · Boehringer Mannheim Corp. · Dec 1997
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412 · Bayer Corp. · Jun 1996
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
K951638 · Organon Teknika Corp. · May 1995
OPUS(R) CK-MB
K924429 · Pb Diagnostic Systems, Inc. · Oct 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K921763 · Hybritech, Inc. · Jun 1992