Cleared Traditional

CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY (K870987) - FDA 510(k) Clearance

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

K870987 · Ciba Corning Diagnostics Corp. · Chemistry device
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May 1987
Decision
76d
Days
Class 2
Risk

K870987 is an FDA 510(k) clearance for the CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 76 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K870987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1987
Decision Date May 26, 1987
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHX Fluorometric 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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 23
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K870987.
TITAN GEL REP CPK-6 HV
K874144 · Helena Laboratories · Nov 1987
TITAN GEL CPK REP SYSTEM
K873399 · Helena Laboratories · Oct 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171 · American Dade · Sep 1987
CARDIOTRAC CORNING CK ISOENZYME SUBST
K813573 · Corning Medical & Scientific · Jan 1982
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · Beckman Instruments, Inc. · Jan 1981
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · Helena Laboratories · Jul 1980