Cleared Traditional

K800693 - STANBIO PROSTATIC ACID PHOSPHATASE TEST

K800693 is an FDA 510(k) clearance for STANBIO PROSTATIC ACID PHOSPHATASE TEST, manufactured by Stanbio Laboratory. The device is a Class 2 Chemistry device with product code CKE cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K800693 · Stanbio Laboratory · Chemistry device
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Apr 1980
Decision
20d
Days
Class 2
Risk

K800693 is an FDA 510(k) clearance for the STANBIO PROSTATIC ACID PHOSPHATASE TEST. Classified as Acid Phosphatase, Thymolphthale Inmonophosphate (product code CKE), Class II - Special Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K800693

510(k) Number K800693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1980
Decision Date April 16, 1980
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CKE Device Classification - Class 2, Special Controls

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 K800693.
ACID PHOSPHATASE REAGENT SET
K860476 · Sterling Diagnostics, Inc. · Mar 1986
ACID PHOSPHATASE ASSAY KIT
K843380 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
ACID PHOSPHATASE REAGENT SET
K821526 · Anco Medical Reagents & Assoc. · Jun 1982
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524 · Data Medical Associates, Inc. · May 1979