Cleared Special

K993536 - BIO-RAD CODA NEONATAL GALT ASSAY

K993536 is an FDA 510(k) clearance for BIO-RAD CODA NEONATAL GALT ASSAY, manufactured by Bio-Rad. The device is a Class 2 Chemistry device with product code KQP cleared through the Special 510(k) pathway after a 16-day FDA review.

K993536 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
16d
Days
Class 2
Risk

K993536 is an FDA 510(k) clearance for the BIO-RAD CODA NEONATAL GALT ASSAY. Classified as Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (product code KQP), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on November 4, 1999 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1315 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K993536

510(k) Number K993536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1999
Decision Date November 04, 1999
Days to Decision 16 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 89d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

KQP Device Classification - Class 2, Special Controls

Product Code KQP Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1315
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 - KQP Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase

Devices cleared under the same product code (KQP) and FDA review panel - the closest regulatory comparables to K993536.
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
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K100101 · Perkinelmer, Inc. · Jun 2010
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K990827 · Bio-Rad · Apr 1999
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K970277 · Astoria-Pacific, Inc. · Dec 1997
TOTAL GALACTOSE
K894011 · Alpkem Corp. · Jan 1990
K993536 · BIO-RAD CODA NEONATAL GALT ASSAY
Download PDF FDA Summary Bio-Rad