Cleared Traditional

K994221 - BAYER PSA ASSAY

K994221 is an FDA 510(k) clearance for BAYER PSA ASSAY, manufactured by Bayer Corp.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K994221 · Bayer Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
120d
Days
Class 2
Risk

K994221 is an FDA 510(k) clearance for the BAYER PSA ASSAY. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 120 days - within the typical 510(k) review window.

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 Bayer Corp. devices

FDA 510(k) Submission Details - K994221

510(k) Number K994221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1999
Decision Date April 13, 2000
Days to Decision 120 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
15d slower than avg
Panel avg: 105d · This submission: 120d
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 K994221.
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · Dade Behring, Inc. · Feb 2001
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · Bayer Corp. · Oct 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
K994419 · Qualisys Diagnostics, Inc. · Jun 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
K000566 · Ortho-Clinical Diagnostics, Inc. · Mar 2000
QUALISYS PSA IMMUNOASSAY
K990234 · Qualisys Diagnostics, Inc. · Jul 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
K984289 · Ortho-Clinical Diagnostics, Inc. · Mar 1999