Cleared Traditional

WAKO CH50 LINEARITY SET (K973055) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973055 · Wako Chemicals USA, Inc. · Immunology device
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Sep 1997
Decision
41d
Days
Class 2
Risk

K973055 is an FDA 510(k) clearance for the WAKO CH50 LINEARITY SET. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K973055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1997
Decision Date September 25, 1997
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIW Calibrator, Surrogate

All 16
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K973055.
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · Diagnostic Products Corp. · Oct 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · Sigma Chemical Co. · Jul 1990
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980