Cleared Traditional

K790040 - P.A.P. TEST KIT, RIA-ZYME

K790040 is an FDA 510(k) clearance for P.A.P. TEST KIT, manufactured by Mallinckrodt Critical Care. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K790040 · Mallinckrodt Critical Care · Chemistry device
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Apr 1979
Decision
99d
Days
Class 2
Risk

K790040 is an FDA 510(k) clearance for the P.A.P. TEST KIT, RIA-ZYME. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on April 17, 1979 after a review of 99 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 Mallinckrodt Critical Care devices

FDA 510(k) Submission Details - K790040

510(k) Number K790040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1979
Decision Date April 17, 1979
Days to Decision 99 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
11d slower than avg
Panel avg: 88d · This submission: 99d
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.