Cleared Traditional

K791497 - PROSTATIC ACID RADIOIMMUNOASSAY TEST

K791497 is an FDA 510(k) clearance for PROSTATIC ACID RADIOIMMUNOASSAY TEST, manufactured by Clinical Assays, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K791497

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
Combination Product No
PCCP Authorized No
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.

JFH Device Classification - Class 2, Special Controls

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 34
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
RIA KIT, QUANTITATION OF PROSTATIC ACID
K790817 · New England Nuclear · May 1979
P.A.P. TEST KIT, RIA-ZYME
K790040 · Mallinckrodt Critical Care · Apr 1979