Cleared Traditional

SHOT GUN KIT FOR CK-MB (K831391) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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.