Cleared Traditional

K991246 - FRUCTOSAMINE, MODEL FR 106-01

K991246 is an FDA 510(k) clearance for FRUCTOSAMINE, manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K991246 · A.P. Total Care, Inc. · Chemistry device
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Dec 1999
Decision
248d
Days
Class 2
Risk

K991246 is an FDA 510(k) clearance for the FRUCTOSAMINE, MODEL FR 106-01. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 248 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991246

510(k) Number K991246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date December 16, 1999
Days to Decision 248 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 88d · This submission: 248d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 172
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K991246.
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
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · Abbott Laboratories · Nov 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · Roche Diagnostics Corp. · Sep 1999
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · Bio-Rad · Dec 1998