Cleared Traditional

K011434 - G7 AUTOMATED HPLC ANALYZER

K011434 is the FDA 510(k) clearance for G7 AUTOMATED HPLC ANALYZER by Tosoh Medics, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K011434 · Tosoh Medics, Inc. · Hematology device
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Sep 2001
Decision
131d
Days
Class 2
Risk

K011434 is an FDA 510(k) clearance for the G7 AUTOMATED HPLC ANALYZER. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 131 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

Submission Details

510(k) Number K011434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date September 18, 2001
Days to Decision 131 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
18d slower than avg
Panel avg: 113d · This submission: 131d
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 K011434.
RANDOX HAEMOGLOBIN A1C
K021897 · Randox Laboratories, Ltd. · Nov 2002
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · Dade Behring, Inc. · Nov 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · Sigma Diagnostics, Inc. · Oct 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · Beckman Coulter, Inc. · Jul 2001
VARIANT II TOTAL GHB
K003280 · Bio-Rad · Dec 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · Roche Diagnostics Corp. · Dec 2000