Cleared Traditional

CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY (K001943) - FDA 510(k) Clearance

Class I Chemistry device.

K001943 · Sangui Biotech, Inc. · Chemistry device
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Aug 2000
Decision
58d
Days
Class 1
Risk

K001943 is an FDA 510(k) clearance for the CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY. Classified as Test, Carbohydrate Deficient Transferrin (product code NAO), Class I - General Controls.

Submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 23, 2000 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - 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: 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 Sangui Biotech, Inc. devices

Submission Details

510(k) Number K001943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2000
Decision Date August 23, 2000
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAO Test, Carbohydrate Deficient Transferrin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
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.