Cleared Traditional

K915792 - DOCUMENT CK ISOENZYMES CONTROL

K915792 is the FDA 510(k) clearance for DOCUMENT CK ISOENZYMES CONTROL by Casco Standards. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K915792 · Casco Standards · Chemistry device
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Feb 1992
Decision
44d
Days
Class 2
Risk

K915792 is an FDA 510(k) clearance for the DOCUMENT CK ISOENZYMES CONTROL. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on February 6, 1992 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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.

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Submission Details

510(k) Number K915792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date February 06, 1992
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 93
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K915792.
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · Heraeus Kulzer, Inc. · Sep 1992
TOTAL T3 CHEMILUMINESCENCE ASSAY
K923015 · Nichols Institute Diagnostics · Sep 1992
MILENIA TOTAL T3
K914467 · Diagnostic Products Corp. · Feb 1992
OPUS T3 TEST SYSTEM
K905410 · Pb Diagnostic Systems, Inc. · Feb 1991
IMX FREE TRIIODOTHYRONINE
K905261 · Abbott Laboratories · Jan 1991
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · Immunotech Corp. · Dec 1990