Cleared Traditional

K994419 - FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

K994419 is an FDA 510(k) clearance for FASTPACK 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 182-day FDA review.

K994419 · Qualisys Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
182d
Days
Class 2
Risk

K994419 is an FDA 510(k) clearance for the FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Qualisys Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 28, 2000 after a review of 182 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.

FDA 510(k) Submission Details - K994419

510(k) Number K994419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1999
Decision Date June 28, 2000
Days to Decision 182 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
77d slower than avg
Panel avg: 105d · This submission: 182d
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 33
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K994419.
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
K003094 · Qualigen, Inc. · Oct 2000
TOTAL PSA MICROTITER ELISA
K002121 · Oncogene Science, Inc. · Aug 2000
COMPLEXED PSA MICROTITER ELISA
K002313 · Oncogene Science, Inc. · Aug 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
QUALISYS PSA IMMUNOASSAY
K990234 · Qualisys Diagnostics, Inc. · Jul 1999
K994419 · FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
Download PDF FDA Summary Qualisys Diagnostics,…