Cleared Traditional

K991483 - ABBOTT ARCHITECT GLYCATED HEMOGLOBIN

K991483 is an FDA 510(k) clearance for ABBOTT ARCHITECT GLYCATED HEMOGLOBIN, manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K991483 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
187d
Days
Class 2
Risk

K991483 is an FDA 510(k) clearance for the ABBOTT ARCHITECT GLYCATED HEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 1, 1999 after a review of 187 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K991483

510(k) Number K991483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date November 01, 1999
Days to Decision 187 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 113d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 Hematology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 149
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K991483.
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · Abbott Laboratories · May 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · Genzyme Corp. · Mar 2000
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590 · Pointe Scientific, Inc., · Dec 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · Roche Diagnostics Corp. · Sep 1999
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · Bio-Rad · Dec 1998
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · Genzyme Corp. · Nov 1998