Cleared Traditional

K821526 - ACID PHOSPHATASE REAGENT SET

K821526 is the FDA 510(k) clearance for ACID PHOSPHATASE REAGENT SET by Anco Medical Reagents & Assoc.. It is a Class 2 Chemistry device (product code CKE) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K821526 · Anco Medical Reagents & Assoc. · Chemistry device
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Jun 1982
Decision
20d
Days
Class 2
Risk

K821526 is an FDA 510(k) clearance for the ACID PHOSPHATASE REAGENT SET. Classified as Acid Phosphatase, Thymolphthale Inmonophosphate (product code CKE), Class II - Special Controls.

Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - 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 Anco Medical Reagents & Assoc. devices

Submission Details

510(k) Number K821526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1982
Decision Date June 10, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CKE Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - CKE Acid Phosphatase, Thymolphthale Inmonophosphate

All 7
Devices cleared under the same product code (CKE) and FDA review panel - the closest regulatory comparables to K821526.
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K864230 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1986
ACID PHOSPHATASE REAGENT SET
K860476 · Sterling Diagnostics, Inc. · Mar 1986
ACID PHOSPHATASE ASSAY KIT
K843380 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · Stanbio Laboratory · Apr 1980
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524 · Data Medical Associates, Inc. · May 1979