Cleared Traditional

K972265 - A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER

K972265 is an FDA 510(k) clearance for A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBI..., manufactured by Tosoh Medics, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K972265 · Tosoh Medics, Inc. · Hematology device
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Sep 1997
Decision
100d
Days
Class 2
Risk

K972265 is an FDA 510(k) clearance for the A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 100 days - within the typical 510(k) review window.

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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K972265

510(k) Number K972265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date September 25, 1997
Days to Decision 100 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
13d faster than avg
Panel avg: 113d · This submission: 100d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K972265.
AIC - CHEK (HBAIC-I)
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K973696 · Beckman Instruments, Inc. · Nov 1997
EZCHEK/HBA BLOOD COLLECTION KIT
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LXN FRUCTOSAMINE TEST SYSTEM
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HYDRAGEL 15 HB A1C KIT
K963844 · Morax · Apr 1997