Cleared Traditional

K973072 - WAKO NEFA LINEARITY SET

K973072 is the FDA 510(k) clearance for WAKO NEFA LINEARITY SET by Wako Chemicals USA, Inc.. It is a Class 1 Toxicology device (product code JJX) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K973072 · Wako Chemicals USA, Inc. · Toxicology device

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Sep 1997

Decision

25d

Days

Class 1

Risk

K973072 is an FDA 510(k) clearance for the WAKO NEFA LINEARITY SET. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology 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	K973072 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1997
Decision Date	September 12, 1997
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

62d faster than avg

Panel avg: 87d · This submission: 25d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1660

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370

Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K973072.

SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)

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OPUS HLH CONTROLS

K973832 · Behring Diagnostics, Inc. · Oct 1997

MYOGLOBIN CONTROL SET

K973358 · Boehringer Mannheim Corp. · Oct 1997

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P

K972721 · Roche Diagnostic Systems, Inc. · Aug 1997

LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS

K971014 · Lifescan, Inc. · Apr 1997

IMMULITE THYROID AUTOANTIBODY CONTROL MODULE

K971051 · Diagnostic Products Corp. · Apr 1997

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K973072

Wako Chemicals USA, Inc.

Richmond, VA · US

TONYA MALLORY

Regulatory profile

124 submissions 123 cleared

99% clearance rate · Active in Toxicology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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