Cleared Traditional

K920449 - POINTE 750 GLYCOMETER

K920449 is the FDA 510(k) clearance for POINTE 750 GLYCOMETER by Pointe Scientific, Inc.,. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K920449 · Pointe Scientific, Inc., · Hematology device
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Jul 1992
Decision
177d
Days
Class 2
Risk

K920449 is an FDA 510(k) clearance for the POINTE 750 GLYCOMETER. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on July 28, 1992 after a review of 177 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K920449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1992
Decision Date July 28, 1992
Days to Decision 177 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 113d · This submission: 177d
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 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K920449.
IMX(R) GLYCATED HEMOGLOBIN
K921831 · Abbott Laboratories · Sep 1992
MODIFICATION COLUMNMATE
K920820 · Helena Laboratories · Aug 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397 · Medical Analysis Systems, Inc. · Aug 1992
COLUMNMATE II
K921676 · Helena Laboratories · Jul 1992
GLYCO-TEK AFFINITY COLUMN KIT
K921305 · Helena Laboratories · Jun 1992
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · Boehringer Mannheim Corp. · Dec 1991