Cleared Special

K990827 - MICROPLATE NEONATAL GALT ASSAY

K990827 is an FDA 510(k) clearance for MICROPLATE 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 28-day FDA review.

K990827 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
28d
Days
Class 2
Risk

K990827 is an FDA 510(k) clearance for the MICROPLATE 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 April 9, 1999 after a review of 28 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 - K990827

510(k) Number K990827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1999
Decision Date April 09, 1999
Days to Decision 28 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
61d faster than avg
Panel avg: 89d · This submission: 28d
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 K990827.
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
K101392 · Astoria-Pacific, Inc. · Feb 2011
GSP NEONATALGALT KIT, MODEL 3303-001U
K100101 · Perkinelmer, Inc. · Jun 2010
BIO-RAD CODA NEONATAL GALT ASSAY
K993536 · Bio-Rad · Nov 1999
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
K970277 · Astoria-Pacific, Inc. · Dec 1997
TOTAL GALACTOSE
K894011 · Alpkem Corp. · Jan 1990
K990827 · MICROPLATE NEONATAL GALT ASSAY
Download PDF FDA Summary Bio-Rad