Cleared Traditional

K895723 - IRMA-COUNT(TM) PAP

K895723 is the FDA 510(k) clearance for IRMA-COUNT(TM) PAP by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K895723 · Diagnostic Products Corp. · Chemistry device
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Oct 1989
Decision
36d
Days
Class 2
Risk

K895723 is an FDA 510(k) clearance for the IRMA-COUNT(TM) PAP, (RKPA1, RKPA2). 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 October 31, 1989 after a review of 36 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 K895723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date October 31, 1989
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 26
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K895723.
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
K921745 · Hybritech, Inc. · Jul 1992
MILENIA PAP IRMA CATALOG #: MKPA1, X
K902937 · Diagnostic Products Corp. · Sep 1990
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
K901933 · Diagnostic Products Corp. · Jun 1990
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · Baxter Healthcare Corp · Aug 1989
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
K884748 · Technicon Instruments Corp. · Jan 1989
ABBOTT PAP-EIA
K873903 · Abbott Laboratories · Dec 1987