Cleared Special

K060650 - VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314

Also marketed or referenced as:
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

K060650 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 24-day FDA review.

K060650 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
24d
Days
Class 2
Risk

K060650 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 6, 2006 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060650

510(k) Number K060650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2006
Decision Date April 06, 2006
Days to Decision 24 days
Submission Type Special
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
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 247
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K060650.
HBA1C
K063209 · Thermo Electron OY · Mar 2007
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
K063643 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · Dec 2006
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · Bio-Rad Laboratories, Inc. · Dec 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · Microgenics Corp. · Feb 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · Bio-Rad Laboratories, Inc. · Jan 2006
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464 · Roche Diagnostics Corp. · Sep 2005
K060650 · VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
Download PDF FDA Summary Ortho-Clinical Diagno…