Cleared Traditional

K131580 - AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-...

K131580 is an FDA 510(k) clearance for AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-..., manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code PDJ cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K131580 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
237d
Days
Class 2
Risk

K131580 is an FDA 510(k) clearance for the AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on January 23, 2014 after a review of 237 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - 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 Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K131580

510(k) Number K131580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2013
Decision Date January 23, 2014
Days to Decision 237 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDJ Device Classification - Class 2, Special Controls

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
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 - PDJ Hemoglobin A1c Test System

All 22
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K131580.
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · Abbott Laboratories · May 2015
VARIANT II TURBO HbA1c Kit - 2.0
K142448 · Bio-Rad Laboratories, Inc. · Mar 2015
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · Abbott Laboratories · Feb 2014
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
DEN130002 · Roche Diagnostics · May 2013