Cleared Traditional

K020972 - WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET

K020972 is an FDA 510(k) clearance for WAKO RF-HA (2), manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K020972 · Wako Chemicals USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
167d
Days
Class 2
Risk

K020972 is an FDA 510(k) clearance for the WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 9, 2002 after a review of 167 days - an extended review 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: 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K020972

510(k) Number K020972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2002
Decision Date September 09, 2002
Days to Decision 167 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
62d slower than avg
Panel avg: 105d · This submission: 167d
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 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K020972.
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · Zeus Scientific, Inc. · Feb 2004
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · Roche Diagnostics Corp. · Sep 2003
RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · Diamedix Corp. · Jul 2002
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · Roche Diagnostics Corp. · Sep 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · Roche Diagnostics Corp. · Apr 2000