Cleared Traditional

K990234 - QUALISYS PSA IMMUNOASSAY

K990234 is an FDA 510(k) clearance for QUALISYS PSA IMMUNOASSAY, manufactured by Qualisys Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K990234 · Qualisys Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
164d
Days
Class 2
Risk

K990234 is an FDA 510(k) clearance for the QUALISYS PSA IMMUNOASSAY. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Qualisys Diagnostics, Inc. (Irvine, US). The FDA issued a Cleared decision on July 8, 1999 after a review of 164 days - an extended review cycle.

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. Standard predicate reliance. 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 Qualisys Diagnostics, Inc. devices

FDA 510(k) Submission Details - K990234

510(k) Number K990234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date July 08, 1999
Days to Decision 164 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
59d slower than avg
Panel avg: 105d · This submission: 164d
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 28
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K990234.
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
K994419 · Qualisys Diagnostics, Inc. · Jun 2000
BAYER PSA ASSAY
K994221 · Bayer Corp. · Apr 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
K000566 · Ortho-Clinical Diagnostics, Inc. · Mar 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
K984289 · Ortho-Clinical Diagnostics, Inc. · Mar 1999
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · Boehringer Mannheim Corp. · Oct 1998
ELECSYS PSA, MODEL 2010
K982949 · Boehringer Mannheim Corp. · Oct 1998