Cleared Traditional

K944664 - WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (FDA 510(k) Clearance)

Class I Chemistry device.

K944664 · Wako Chemicals USA, Inc. · Chemistry device
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Feb 1995
Decision
138d
Days
Class 1
Risk

K944664 is an FDA 510(k) clearance for the WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K944664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date February 07, 1995
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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.