Cleared Traditional

K843007 - CARDI-CK EIA TEST KIT CK-MB ISOENZYME

K843007 is an FDA 510(k) clearance for CARDI-CK EIA TEST KIT CK-MB ISOENZYME, manufactured by Intl. Immunoassay Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHS cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K843007 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Sep 1984
Decision
38d
Days
Class 2
Risk

K843007 is an FDA 510(k) clearance for the CARDI-CK EIA TEST KIT CK-MB ISOENZYME. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 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.

View all Intl. Immunoassay Laboratories, Inc. devices

FDA 510(k) Submission Details - K843007

510(k) Number K843007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date September 07, 1984
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
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHS Device Classification - Class 2, Special Controls

Product Code JHS Differential Rate Kinetic 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 - JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 34
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K843007.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387 · Eastman Kodak Company · Jun 1986
CPK (UV) REAGENT KIT
K855188 · Technostics Intl. · Mar 1986
DART CK-MB REAGENT SYSTEM
K854708 · Coulter Electronics, Inc. · Dec 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722 · Eastman Kodak Company · Apr 1982
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406 · Pointe Scientific, Inc., · Dec 1981
WORTHINGTON CK (NAC) REAGENT SET
K810997 · Worthington Diagnostic Systems · Apr 1981