Cleared Traditional

K872063 - TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKM...

K872063 is the FDA 510(k) clearance for TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKM... by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JHY) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K872063 · Hybritech, Inc. · Chemistry device
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Jun 1987
Decision
22d
Days
Class 2
Risk

K872063 is an FDA 510(k) clearance for the TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on June 19, 1987 after a review of 22 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 Hybritech, Inc. devices

Submission Details

510(k) Number K872063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date June 19, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 29
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K872063.
IMX CKMB
K883013 · Abbott Laboratories · Aug 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192 · Eastman Kodak Company · Feb 1988
CREATINE KINASE (COLORIMETRIC METHOD)
K880178 · Tech-Co, Inc. · Feb 1988
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
K871677 · Catachem, Inc. · May 1987
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
K860663 · Amresco, Inc. · Apr 1986
BAKER CKMB REAGENT SET
K845024 · Hybritech, Inc. · Jan 1985