Cleared Traditional

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 K921745.
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IMMULITE PAP
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K925377 · Abbott Laboratories · Jan 1993
MILENIA PAP IRMA CATALOG #: MKPA1, X
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K901933 · Diagnostic Products Corp. · Jun 1990
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · Diagnostic Products Corp. · Oct 1989