Cleared Traditional

K772257 - ALKALINE PHOSPHATASE TEST SET

K772257 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE TEST SET, manufactured by Stanbio Laboratory. The device is a Class 2 Chemistry device with product code CIO cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K772257 · Stanbio Laboratory · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1977
Decision
17d
Days
Class 2
Risk

K772257 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE TEST SET. Classified as Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (product code CIO), Class II - Special Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on December 22, 1977 after a review of 17 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K772257

510(k) Number K772257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1977
Decision Date December 22, 1977
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIO Device Classification - Class 2, Special Controls

Product Code CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or 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 - CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

All 8
Devices cleared under the same product code (CIO) and FDA review panel - the closest regulatory comparables to K772257.
ALKALINE PHOSPHOTASE REAGENT SET
K841064 · Medical Specialties, Inc. · May 1984
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578 · Hoffmann-La Roche, Inc. · Jan 1983
ALKALINE PHOSPHOTASE REAGENT SET
K821200 · Omega Medical Electronics · Jul 1982
PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
K770453 · Icn Pharmaceuticals, Inc. · May 1977