Cleared Traditional

K974816 - ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

K974816 is an FDA 510(k) clearance for ACCESS PSA REAGENTS ON THE ACCESS IMMUN..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K974816 · Beckman Instruments, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
59d
Days
Class 2
Risk

K974816 is an FDA 510(k) clearance for the ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K974816

510(k) Number K974816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1997
Decision Date February 20, 1998
Days to Decision 59 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
46d faster than avg
Panel avg: 105d · This submission: 59d
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 K974816.
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · Bayer Corp. · Apr 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · Diagnostic Products Corp. · Apr 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716 · Nichols Institute Diagnostics · Apr 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189 · Boehringer Mannheim Corp. · Jan 1998
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · Diagnostic Products Corp. · Oct 1997
PROSTATE SPECIFIC ANTIGEN METHOD
K973101 · Dade Chemistry Systems, Inc. · Sep 1997