510(k) Report

510(k) · Cleared

Cleared

Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702

K060650510(k) SpecialCleared Apr 6, 200624-day reviewClass II21 CFR 864.7470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ortho-Clinical Diagnostics, Inc. · LCP Assay, Glycosylated Hemoglobin

Cleared on Apr 6, 2006 as substantially equivalent to K041764 (Ortho-Clinical Diagnostics, 2004) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 2000.

Decided
Apr 6, 2006
Review
24 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K000534 (2000). 6 ancestors in all, the oldest K904768 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor1997: 1 other ancestor1990: 1 other ancestorK000534 · Cobas Integra Reagent Cassette for Rheumatoid Factor II · Roche Diagnostics Corp. · 2000K041863 · Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FS · Ortho-Clinical Diagnostics, Inc. · 2004 · recalledK052645 · Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873; · Ortho-Clinical Diagnostics · 20051990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors K052645 · Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873; · Ortho-Clinical Diagnostics · 2005K041863 · Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FS · Ortho-Clinical Diagnostics, Inc. · 2004 · recalledK000534 · Cobas Integra Reagent Cassette for Rheumatoid Factor II · Roche Diagnostics Corp. · 20000
  1. Root · 3 generations backK000534 Cobas Integra Reagent Cassette for Rheumatoid Factor IIRoche Diagnostics Corp. · 2000
  2. 2 generations backK041863 Vitros Chemistry Products RF Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
  3. 1 generation backK052645 Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros…Ortho-Clinical Diagnostics · 2005
  4. This deviceK060650 Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000534Cobas Integra Reagent Cassette for Rheumatoid Factor IIRoche Diagnostics Corp.2000—
−2K041863Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20041
−1K052645Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry…Ortho-Clinical Diagnostics2005—
0 (this device)K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry…Ortho-Clinical Diagnostics, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199710
200410
FIG. 1 — Lineage of K060650, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LCP device

  1. #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K041764The Vitros 5,1 FS Chemistry System
Summary page 1
…and VITROS FS Calibrator 1 which were cleared by the FDA for in vitro diagnostic use. VITROS %Alc Reagent Kit: (K041764, Cleared September 9, 2004) VITROS Calibrator Kit 18: (K041764, Cleared September 9, 2004)…
Ortho-Clinical Diagnostics2004—
*K052645Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS…
Summary page 1
…t: (K041764, Cleared September 9, 2004) VITROS Calibrator Kit 18: (K041764, Cleared September 9, 2004) VITROS FS Calibrator 1: (K052645, Cleared December 14, 2005). Ortho-Clinical Diagnostics VITROS Chemistry Products d%Alc Assay 18 ===…
Ortho-Clinical Diagnostics2005—

Also cleared against K041764: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K041764.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCP

1in 2024

2007: 72008: 52009: 62010: 22011: 102012: 92013: 22014: 82015: 32016: 22017: 52018: 22019: 42020: 12023: 22024: 1
2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007: 133 days median2008: 206 days median2009: 158 days median2011: 176 days median2012: 143 days median2014: 127 days median2015: 239 days median2017: 218 days median2019: 269 days median
2007high 269 (2019) · low 127 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCP

1in 2025

2007: 12008: 32009: 62010: 52011: 512013: 42014: 22015: 22016: 62017: 12018: 12022: 12024: 12025: 1
2007high 51 (2011) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LCP

22in 2025

2007: 52008: 112009: 152010: 42011: 272012: 512013: 1932014: 1822015: 642016: 292017: 1492018: 1,9112019: 1142020: 132021: 72022: 82023: 272024: 392025: 22
2007high 1,911 (2018) · low 4 (2010)2025

MAUDE reports naming product code LCP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007713315
20085206311
20096158615
20102—54
2011101765127
20129143051
20132—4193
201481272182
20153239264
20162—629
201752181149
20182—11,911
201942690114
20201—013
20210—07
20220—18
20232—027
20241—139
20250—122
20260—0—

What is it indicated for?

For in vitro diagnostic use only. VITROS Chemistry Products d%Alc Reagent Kit is used to determine the percent glycated hemoglobin (%AI c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin Alc (HbAlc). Measurements of percentage Alc are effective in monitoring long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 18 is used in…

Read the full statement (125 words)

For in vitro diagnostic use only.

VITROS Chemistry Products d%Alc Reagent Kit is used to determine the percent glycated hemoglobin (%AI c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin Alc (HbAlc). Measurements of percentage Alc are effective in monitoring long-term glycemic control in individuals with diabetes mellitus.

For in vitro diagnostic use only.

VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator I to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%Alc).

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator I is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19 and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

Indications for use as stated in the FDA summary.

Also cleared against K041764

2 other devices cite the same predicate.

  • K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c…Ortho Clinical Diagnostics · 20152 recalls
  • K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 20092 recalls

More from Ortho-Clinical Diagnostics, Inc.

273 FDA decisions under this applicant name. See the company

  • K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
  • DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • P090028/S018VITROS Immunodiagnostic Products HBeAg Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc. · 2023
  • P030026/S037VITROS Anti-HBc IgMOrtho-Clinical Diagnostics, Inc. · 2023

Recent decisions in LCP

The LCP category page

  • K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  • K231465Q-Pad Test SystemQurasense · 2023
  • K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
  • K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020
  • K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd. · 2019

https://510kreport.com/device/K060650 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060650: Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060650

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026