Cleared Traditional

K771225 - AP ISOTROL, #A 0140

K771225 is an FDA 510(k) clearance for AP ISOTROL, manufactured by Sigma Chemical Co.. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K771225 · Sigma Chemical Co. · Chemistry device
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Aug 1977
Decision
29d
Days
Class 2
Risk

K771225 is an FDA 510(k) clearance for the AP ISOTROL, #A 0140. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1977 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K771225

510(k) Number K771225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date August 03, 1977
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIN Device Classification - Class 2, Special Controls

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 22
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K771225.
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118 · Corning Medical & Scientific · Feb 1983
ALKALINE PHOSPHATASE MARKER
K792548 · Electrophoresis Corp. of America · Jan 1980
ALKALINE PHOSPHATASE ISOENZY. SUB. SET
K771620 · Pfizer, Inc. · Sep 1977
PROCEDURE NO. 710-EP FOR ALK.PHOS.
K760862 · Sigma Chemical Co. · Nov 1976