Cleared Traditional

K801318 - HELENA ULTRA SENSITIVE CPK REAGENT/DILUE

K801318 is an FDA 510(k) clearance for HELENA ULTRA SENSITIVE CPK REAGENT/DILUE, manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K801318 · Helena Laboratories · Chemistry device
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Jul 1980
Decision
36d
Days
Class 2
Risk

K801318 is an FDA 510(k) clearance for the HELENA ULTRA SENSITIVE CPK REAGENT/DILUE. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 36 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 Helena Laboratories devices

FDA 510(k) Submission Details - K801318

510(k) Number K801318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1980
Decision Date July 14, 1980
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

Product Code JHX Fluorometric 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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 41
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K801318.
NML CK-MB RIA
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PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · Beckman Instruments, Inc. · Jan 1981
EMBRIA-CK
K801728 · Intl. Immunoassay Laboratories, Inc. · Sep 1980
CORNING TRANSPHOR
K800544 · Corning Medical & Scientific · Mar 1980
RIA-QUANT CK-MB TEST KIT
K792504 · Mallinckrodt Critical Care · Jan 1980
BUFFER, CORNING MOPSO
K790294 · Corning Medical & Scientific · Mar 1979