Cleared Traditional

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 (K901933) - FDA 510(k) Clearance

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

K901933 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
59d
Days
Class 2
Risk

K901933 is an FDA 510(k) clearance for the COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2. 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 June 28, 1990 after a review of 59 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 K901933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date June 28, 1990
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 K901933.
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257 · Diagnostic Products Corp. · Feb 2000
IMMULITE PAP
K931701 · Diagnostic Products Corp. · Jan 1994
IMX PAP
K925377 · Abbott Laboratories · Jan 1993
MILENIA PAP IRMA CATALOG #: MKPA1, X
K902937 · Diagnostic Products Corp. · Sep 1990
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · Diagnostic Products Corp. · Oct 1989
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · Baxter Healthcare Corp · Aug 1989