Cleared Traditional

K000534 - COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

K000534 is an FDA 510(k) clearance for COBAS INTEGRA REAGENT CASSETTE FOR RHEU..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K000534 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
48d
Days
Class 2
Risk

K000534 is an FDA 510(k) clearance for the COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 5, 2000 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K000534

510(k) Number K000534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date April 05, 2000
Days to Decision 48 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
57d faster than avg
Panel avg: 105d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 108
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K000534.
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · Wako Chemicals USA, Inc. · Sep 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · Diamedix Corp. · Jul 2002
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · Roche Diagnostics Corp. · Sep 2000
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557 · Cogent Diagnotics , Ltd. · Mar 2000
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · Cogent Diagnotics , Ltd. · Feb 2000
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · Cogent Diagnotics , Ltd. · Dec 1999