Cleared Traditional

K791735 - PAP RIA KIT

K791735 is the FDA 510(k) clearance for PAP RIA KIT by Nuclear Medical Systems, Inc.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K791735 · Nuclear Medical Systems, Inc. · Chemistry device
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Nov 1979
Decision
77d
Days
Class 2
Risk

K791735 is an FDA 510(k) clearance for the PAP RIA KIT. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Nuclear Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1979 after a review of 77 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 Nuclear Medical Systems, Inc. devices

Submission Details

510(k) Number K791735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1979
Decision Date November 15, 1979
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
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 K791735.
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