Cleared Traditional

K944664 - WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR

K944664 is an FDA 510(k) clearance for WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN..., manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code JIQ cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K944664

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

JIQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 11
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