Cleared Traditional

K921745 - HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

K921745 is an FDA 510(k) clearance for HYBRITECH STRATUS PAP FLUOROMETRIC ENZY..., manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K921745 · Hybritech, Inc. · Chemistry device
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Jul 1992
Decision
108d
Days
Class 2
Risk

K921745 is an FDA 510(k) clearance for the HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 108 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 Hybritech, Inc. devices

FDA 510(k) Submission Details - K921745

510(k) Number K921745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date July 30, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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.

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 K921745.
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
K964756 · Wano-Tech Corp. · Apr 1997
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
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