Cleared Traditional

K832977 - FLOW-PAC CPK REAGENT SET

K832977 is an FDA 510(k) clearance for FLOW-PAC CPK REAGENT SET, manufactured by American Research Products Co.. The device is a Class 2 Chemistry device with product code JHY cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K832977 · American Research Products Co. · Chemistry device
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Apr 1984
Decision
216d
Days
Class 2
Risk

K832977 is an FDA 510(k) clearance for the FLOW-PAC CPK REAGENT SET. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 216 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 American Research Products Co. devices

FDA 510(k) Submission Details - K832977

510(k) Number K832977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1983
Decision Date April 05, 1984
Days to Decision 216 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
128d slower than avg
Panel avg: 88d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHY Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K832977.
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
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
K832139 · Hybritech, Inc. · Aug 1983
WAKO CPK TEST
K832004 · Wako Chemicals USA, Inc. · Aug 1983
CREATINE KINASE-MB KIT
K820812 · Calbiochem-Behring Corp. · Apr 1982