Cleared Traditional

K160762 - Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

K160762 is an FDA 510(k) clearance for Diazyme Direct HbA1c Assay (Enzymatic, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K160762 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
245d
Days
Class 2
Risk

K160762 is an FDA 510(k) clearance for the Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c .... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 21, 2016 after a review of 245 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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 Diazyme Laboratories devices

FDA 510(k) Submission Details - K160762

510(k) Number K160762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date November 21, 2016
Days to Decision 245 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 88d · This submission: 245d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 231
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K160762.
cobas HbA1c Test, cobas b 101 system
K163633 · Roche Diagnostics Operations · Jul 2017
A1C EZ Glycohemoglobin Analysis System
K161533 · Biohermes Co., Ltd. · Jun 2017
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
K162281 · Sebia · Feb 2017
URight Hemoglobin A1c system, FORA A1c System
K142664 · Taidoc Technology Corporation · Jan 2016
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
K140827 · Sd Biosensor, Inc. · Sep 2015
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
K151809 · Alere Technologies AS · Sep 2015