Cleared Traditional

MILENIA PAP IRMA CATALOG #: MKPA1, X (K902937) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K902937 · Diagnostic Products Corp. · Chemistry device
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Sep 1990
Decision
80d
Days
Class 2
Risk

K902937 is an FDA 510(k) clearance for the MILENIA PAP IRMA CATALOG #: MKPA1, X. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on September 21, 1990 after a review of 80 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K902937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date September 21, 1990
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
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 44
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K902937.
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IMMULITE PAP
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K925377 · Abbott Laboratories · Jan 1993
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
K901933 · Diagnostic Products Corp. · Jun 1990
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · Diagnostic Products Corp. · Oct 1989
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · Baxter Healthcare Corp · Aug 1989