510(k) · Cleared
ClearedVitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Cleared on Dec 14, 2005 as substantially equivalent to K041863 (Ortho-Clinical Diagnostics, Inc., 2004) after a 79-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Dec 14, 2005
- Review
- 79 days
- Class
- Class I
- Product code
- GTQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000534 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000534 Cobas Integra Reagent Cassette for Rheumatoid Factor IIRoche Diagnostics Corp. · 2000
- 1 generation backK041863 Vitros Chemistry Products RF Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- This deviceK052645 Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros…Ortho-Clinical Diagnostics · 2005
- 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 1 of 1 · See all- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000534 | Cobas Integra Reagent Cassette for Rheumatoid Factor II | Roche Diagnostics Corp. | 2000 | — |
| −1 | K041863 | Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit… | Ortho-Clinical Diagnostics, Inc. | 2004 | 1 |
| 0 (this device) | K052645 | Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry… | Ortho-Clinical Diagnostics | 2005 | — |
| +1 | K060650 | Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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 GTQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041863 | Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16…Summary page 1…r 1 and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. The predicate devices were cleared by the FDA (K041863) for IVD use. Ortho-Clinical Diagnostics, Inc. VITROS Calibrator Kit 28, VITROS FS Calibrator I, and VITROS ASO/RF Performanc… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060650 | Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products… | 2006 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K060650 (Ortho-Clinical Diagnostics, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GTQ devicesGTQ Antistreptolysin - Titer/Streptolysin O Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTQ
FDA has decided no GTQ device since 2007.
Median 510(k) review, days · GTQ
Too few GTQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GTQ
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTQ
1in 2025
MAUDE reports naming product code GTQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator Kit 28 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin 0 (ASO).
For in vitro diagnostic use only.
VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only.
VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052645: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052645
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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