Not Cleared Post-NSE

DEN990008 - WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000 (FDA 510(k) Clearance)

Also includes:
NB-4000

Class II Chemistry device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN990008 · Wallac, Inc. · Chemistry device
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Feb 2000
Decision
57d
Days
Class 2
Risk

DEN990008 is an FDA 510(k) submission (not cleared) for the WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000. Classified as System, Test, Biotinidase (product code NAK), Class II - Special Controls.

Submitted by Wallac, Inc. (Norton, US). The FDA issued a Not Cleared (DENG) decision on February 15, 2000 after a review of 57 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1118 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

View all Wallac, Inc. devices

Submission Details

510(k) Number DEN990008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 20, 1999
Decision Date February 15, 2000
Days to Decision 57 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics

Device Classification

Product Code NAK System, Test, Biotinidase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1118
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 Chemistry devices follow this clearance model.