Cleared Traditional

K890295 - TARGET(TM) CK-MB

K890295 is the FDA 510(k) clearance for TARGET(TM) CK-MB by V-Tech, Inc.. It is a Class 2 Chemistry device (product code JHY) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K890295 · V-Tech, Inc. · Chemistry device
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Aug 1989
Decision
208d
Days
Class 2
Risk

K890295 is an FDA 510(k) clearance for the TARGET(TM) CK-MB. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 208 days - an extended review 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: 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 V-Tech, Inc. devices

Submission Details

510(k) Number K890295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1989
Decision Date August 15, 1989
Days to Decision 208 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 88d · This submission: 208d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHY Colorimetric Method, Cpk Or Isoenzymes

All 30
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K890295.
AMERLITE CK-MB ASSAY
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CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K884085 · Hybritech, Inc. · Dec 1988
IMX CKMB
K883013 · Abbott Laboratories · Aug 1988