Cleared Traditional

K855192 - ALKALINE PHOSPHATASE REAGENT SET

K855192 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE REAGENT SET, manufactured by Technostics Intl.. The device is a Class 2 Chemistry device with product code CIO cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K855192 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
19d
Days
Class 2
Risk

K855192 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT SET. Classified as Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (product code CIO), Class II - Special Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

FDA 510(k) Submission Details - K855192

510(k) Number K855192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
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 K855192.
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
K880177 · Tech-Co, Inc. · Apr 1988
ALKALINE PHOSPHATASE REAGENT SET
K860351 · Sterling Diagnostics, Inc. · Feb 1986
SANDARE ALKALINE PHOSPHATASE PROCEDURE
K844498 · Sandare Chemical Co., Inc. · Dec 1984
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