Cleared Traditional

K893508 - PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI

K893508 is an FDA 510(k) clearance for PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCH..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Pathology device with product code JFH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K893508 · Baxter Healthcare Corp · Pathology device
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Aug 1989
Decision
91d
Days
Class 2
Risk

K893508 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on August 4, 1989 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.1020 - the FDA pathology device 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K893508

510(k) Number K893508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1989
Decision Date August 04, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 77d · This submission: 91d
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 Pathology devices follow this clearance model.

Regulatory Peers - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 34
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K893508.
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
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · Diagnostic Products Corp. · Oct 1989
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
K884748 · Technicon Instruments Corp. · Jan 1989
ABBOTT PAP-EIA
K873903 · Abbott Laboratories · Dec 1987
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · Hybritech, Inc. · Jan 1987