510(k) Report

510(k) · Cleared

Cleared

The Vitros 5,1 FS Chemistry System

K041764510(k) TraditionalCleared Sep 9, 200471-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 · LCP Assay, Glycosylated Hemoglobin

Cleared on Sep 9, 2004 as substantially equivalent to K972265 (Tosoh Medics, Inc., 1997) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.

Decided
Sep 9, 2004
Review
71 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K904768 (1990). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2009: 1 descendant cleared2006: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant clearedK904768 · Kodatrol I and II Control and Diluent Set · Eastman Kodak Company · 1990 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant K904768 · Kodatrol I and II Control and Diluent Set · Eastman Kodak Company · 1990 · recalled0
  1. Root · 1 generation backK904768 Kodatrol I and II Control and Diluent SetEastman Kodak Company · 1990 · Recalled
  2. This deviceK041764 The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics · 2004
  3. Descendant · cites it directly · 1 of its ownK081895 Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 2009 · Recalled
  4. Descendant · cites it directly · 0 of its ownK142595 VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit…Ortho Clinical Diagnostics · 2015 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK110934 Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics · 2011 · Recalled
  6. Descendant · cites it directly · 0 of its ownK060650 Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros…Ortho-Clinical Diagnostics, Inc. · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 2009 · cites it directly1descendant
  • K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics · 2015 · cites it directly0descendants
  • K110934Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics · 2011 · 2 generations on0descendants
  • K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904768Kodatrol I and II Control and Diluent SetEastman Kodak Company19901
0 (this device)K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics2004—
+1K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics20092
+1K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS…Ortho Clinical Diagnostics20152
+2K110934Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics20112
+1K060650Vitros 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
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201110
201510
FIG. 1 — Lineage of K041764, 1990–2015Source: 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
*K972265A1C 2.2 Plus - Automated Glycohemoglobin Analyzer
Summary page 3
…Chemistry Products FS Calibrator 1 are substantially equivalent to the Ale 2.2 Plus Glycohemoglobin Assay (Tosoh Medics, Inc.), which was cleared by FDA (K972265) for IVD use. The relationship between the VITROS %Alc assay and the predicate device in NGSP units, determined…
Tosoh Medics, Inc.1997—
*K904768Kodatrol I and II Control and Diluent Set
Summary page 4
…%Alc Performance Verifiers are substantially equivalent to VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use. Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products %Alc Assay and Controls Page 4 of 38 === Page…
Eastman Kodak Company19901

Also cleared against K972265: 1 other device →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics20091
K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics20150
K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.20060

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K081895 (Siemens Medical Solutions Diagnostics, 2009) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K972265.

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 %Alc Reagent Kit is used to calculate percent glycated hemoglobin (%Ale) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin Ale (HbAlc). Measurements of percentage Al c are effective in monitoring long-term glucose 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 (119 words)

For in vitro diagnostic use only. VITROS Chemistry Products %Alc Reagent Kit is used to calculate percent glycated hemoglobin (%Ale) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin Ale (HbAlc). Measurements of percentage Al c are effective in monitoring long-term glucose 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 (%Ale).

For in vitro diagnostic use only. VITROS Chemistry Products %Alc Performance Verifiers are assayed controls used to monitor performance of %Alc Reagent Kit on VITROS 5,1 FS Chemistry Systems.

Indications for use as stated in the FDA summary.

Also cleared against K972265

1 other device cites the same predicate.

  • K011434G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 20012 recalls

More from Ortho-Clinical Diagnostics

70 FDA decisions under this applicant name. See the company

  • P100001/S017VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and CalibratorOrtho-Clinical Diagnostics · 2023
  • P030024/S029VITROS Anti-HBcOrtho-Clinical Diagnostics · 2019
  • P100001/S016VITROS Anti-HBeOrtho-Clinical Diagnostics · 2019
  • P100001/S015VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and CalibratorOrtho-Clinical Diagnostics · 2018
  • P030024/S028VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and CalibratorOrtho-Clinical Diagnostics · 2018

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/K041764 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041764: The Vitros 5,1 FS Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041764

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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