Cleared Traditional

K973243 - ACTIVE PSA ELISA (DSL-10-9700)

K973243 is an FDA 510(k) clearance for ACTIVE PSA ELISA (DSL-10-9700), manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K973243 · Diagnostic Systems Laboratories, Inc. · Immunology device
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Aug 1998
Decision
339d
Days
Class 2
Risk

K973243 is an FDA 510(k) clearance for the ACTIVE PSA ELISA (DSL-10-9700). Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on August 3, 1998 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K973243

510(k) Number K973243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date August 03, 1998
Days to Decision 339 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 105d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTJ Device Classification - Class 2, Special Controls

Product Code LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 Immunology devices follow this clearance model.

Regulatory Peers - LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers

All 30
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K973243.
ELECSYS PSA, MODEL 2010
K982949 · Boehringer Mannheim Corp. · Oct 1998
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
K981634 · Biocircuits Corp. · Oct 1998
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · Chiron Diagnostics Corp. · Aug 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · Diagnostic Systems Laboratories, Inc. · Aug 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · Bayer Corp. · Apr 1998
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K974842 · Diagnostic Products Corp. · Apr 1998