Cleared Traditional

K823550 - CK-ISOZYME U.V. REAGENT SET

K823550 is an FDA 510(k) clearance for CK-ISOZYME U.V. REAGENT SET, manufactured by Gelman Sciences, Inc.. The device is a Class 2 Chemistry device with product code JHT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K823550 · Gelman Sciences, Inc. · Chemistry device
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Jan 1983
Decision
38d
Days
Class 2
Risk

K823550 is an FDA 510(k) clearance for the CK-ISOZYME U.V. REAGENT SET. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 38 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.

FDA 510(k) Submission Details - K823550

510(k) Number K823550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1982
Decision Date January 07, 1983
Days to Decision 38 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
51d faster than avg
Panel avg: 89d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHT Device Classification - Class 2, Special Controls

Product Code JHT Chromatographic Separation, Cpk 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 - JHT Chromatographic Separation, Cpk Isoenzymes

All 20
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K823550.
MICROMI-CK(TM)
K872598 · Intl. Immunoassay Laboratories, Inc. · Aug 1987
IMACK-MB(TM)
K872592 · Intl. Immunoassay Laboratories, Inc. · Jul 1987
SHOT GUN KIT FOR CK-MB
K831391 · Serapine Corp. · Nov 1983
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · Helena Laboratories · Nov 1982
125I QUICK-MB TEST KIT FOR QUANTITATION
K821964 · Intl. Immunoassay Laboratories, Inc. · Jul 1982
GEMENI QUICK-MB SEPARATION KIT
K810534 · Gemini, Inc. · Mar 1981
K823550 · CK-ISOZYME U.V. REAGENT SET
Download PDF Gelman Sciences, Inc.