Cleared Traditional

K991850 - SAFE AT-HOME TEST KIT FOR MONITORING HE...

K991850 is the FDA 510(k) clearance for SAFE AT-HOME TEST KIT FOR MONITORING HE... by Biosafe Laboratories, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K991850 · Biosafe Laboratories, Inc. · Hematology device
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Nov 1999
Decision
178d
Days
Class 2
Risk

K991850 is an FDA 510(k) clearance for the SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Biosafe Laboratories, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 178 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 Biosafe Laboratories, Inc. devices

Submission Details

510(k) Number K991850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date November 26, 1999
Days to Decision 178 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 113d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K991850.
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · Roche Diagnostics Corp. · Dec 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · Abbott Laboratories · May 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