Cleared Traditional

K981634 - BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

K981634 is an FDA 510(k) clearance for BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIG..., manufactured by Biocircuits Corp.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K981634 · Biocircuits Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
158d
Days
Class 2
Risk

K981634 is an FDA 510(k) clearance for the BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS .... Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on October 13, 1998 after a review of 158 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 Biocircuits Corp. devices

FDA 510(k) Submission Details - K981634

510(k) Number K981634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date October 13, 1998
Days to Decision 158 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
53d slower than avg
Panel avg: 105d · This submission: 158d
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 K981634.
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
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · Chiron Diagnostics Corp. · Aug 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · Diagnostic Systems Laboratories, Inc. · Aug 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · Diagnostic Systems Laboratories, Inc. · Aug 1998