Cleared Abbreviated

K043378 - DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOB...

K043378 is the FDA 510(k) clearance for DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOB... by Drew Scientific , Ltd.. It is a Class 2 Chemistry device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 21-day FDA review.

K043378 · Drew Scientific , Ltd. · Chemistry device
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Dec 2004
Decision
21d
Days
Class 2
Risk

K043378 is an FDA 510(k) clearance for the DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Drew Scientific , Ltd. (Barrow In Furness Cumbria, GB). The FDA issued a Cleared decision on December 29, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Drew Scientific , Ltd. devices

Submission Details

510(k) Number K043378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date December 29, 2004
Days to Decision 21 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.

Regulatory Peers - JIT Calibrator, Secondary

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