510(k) · Cleared
Recalled · Class II · 2016Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Dec 28, 2006 as substantially equivalent to K052788 (Dade Behring, Inc., 2006) and 2 other predicates after a 66-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 28, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002852 (2000). 6 ancestors in all, the oldest K992858 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 1 generation backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- This deviceK063206 Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK062105 Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007
Most influential descendants
Showing 1 of 1 · See all- K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −1 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1… | Dade Behring, Inc. | 2006 | — |
| +1 | K062105 | Diazyme Creatinine Liquid Reagents Assay | Diazyme Laboratories | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 LPS? 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? (3)
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 |
|---|---|---|---|
| * | K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HSummary page 1…LPS; JIX; JJY Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex HCY - K052788 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468… | 2006 |
| * | K012470 | Modification to N Protein Standard SLSummary page 1…ical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex HCY - K052788 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 1…ally Marketed Device: Dade Behring N Latex HCY - K052788 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468 tiU d Dade Behring… | 2001 |
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 |
|---|---|---|---|
| K062105 | Diazyme Creatinine Liquid Reagents Assay | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2016 | Class II | Z-2241-2016 | Under Investigation by firm | Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed. |
| Sep 18, 2013 | Class II | Z-0541-2014 | Unknown/Undetermined by firm | Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. |
| Aug 3, 2012 | Class III | Z-0253-2013 | Packaging | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 5.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K062105 (Diazyme Laboratories, 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052788.
How does its category compare?
All LPS devicesLPS Urinary Homocystine (Nonquantitative) Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPS
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LPS
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPS
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPS
1in 2024
MAUDE reports naming product code LPS, 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 | 2 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 4 | 141 | 1 | 0 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 4 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS)…
Read the full statement (133 words)
The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M(jGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista System.
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063206: Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063206
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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