Cleared Traditional

K791497 - PROSTATIC ACID RADIOIMMUNOASSAY TEST

K791497 is the FDA 510(k) clearance for PROSTATIC ACID RADIOIMMUNOASSAY TEST by Clinical Assays, Inc.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K791497 · Clinical Assays, Inc. · Chemistry device
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Dec 1979
Decision
123d
Days
Class 2
Risk

K791497 is an FDA 510(k) clearance for the PROSTATIC ACID RADIOIMMUNOASSAY TEST. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1979 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Assays, Inc. devices

Submission Details

510(k) Number K791497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1979
Decision Date December 04, 1979
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFH Acid Phosphatase (prostatic), Tartrate Inhibited
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 - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 29
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K791497.
CBC PAP TEST KIT
K802153 · Calbiochem-Behring Corp. · Nov 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · Leeco Diagnostics, Inc. · Jan 1980
ELVI ACID & PROSTATIC PHOSPHATASE
K792405 · Volu Sol Medical Industries · Dec 1979
P.A.P. TEST KIT, RIA-ZYME
K790040 · Mallinckrodt Critical Care · Apr 1979