Cleared Traditional

K831391 - SHOT GUN KIT FOR CK-MB

K831391 is an FDA 510(k) clearance for SHOT GUN KIT FOR CK-MB, manufactured by Serapine Corp.. The device is a Class 2 Chemistry device with product code JHT cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K831391 · Serapine Corp. · Chemistry device
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Nov 1983
Decision
189d
Days
Class 2
Risk

K831391 is an FDA 510(k) clearance for the SHOT GUN KIT FOR CK-MB. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Serapine Corp. (Walker, US). The FDA issued a Cleared decision on November 4, 1983 after a review of 189 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 Serapine Corp. devices

FDA 510(k) Submission Details - K831391

510(k) Number K831391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date November 04, 1983
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
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 18
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K831391.
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
K872041 · Coulter Electronics, Inc. · Sep 1987
MICROMI-CK(TM)
K872598 · Intl. Immunoassay Laboratories, Inc. · Aug 1987
IMACK-MB(TM)
K872592 · Intl. Immunoassay Laboratories, Inc. · Jul 1987
CK-ISOZYME U.V. REAGENT SET
K823550 · Gelman Sciences, Inc. · Jan 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