510(k) · Cleared
ClearedDimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MSJ Apolipoproteins
Cleared on Feb 23, 2007 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) and 2 other predicates after an 81-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Feb 23, 2007
- Review
- 81 days
- Class
- Class I
- Product code
- MSJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K023158 (2002). 4 ancestors in all, the oldest K860894 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK023158 Randox Apolipoprotein CalibratorRandox Laboratories, Ltd. · 2002
- 1 generation backK041870 N Apolipoprotein Standard SerumDade Behring, Inc. · 2004
- This deviceK063608 Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1…Dade Behring, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
Most influential descendants
Showing 1 of 1 · See all- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023158 | Randox Apolipoprotein Calibrator | Randox Laboratories, Ltd. | 2002 | — |
| −1 | K041870 | N Apolipoprotein Standard Serum | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1… | Dade Behring, Inc. | 2007 | — |
| +1 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 MSJ? 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 |
|---|---|---|---|
| * | K860894 | Behring Nephelometer SystemSummary page 1…JJY Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Antisera to Human Apo A-1 - K860894 Dade Behring N Antisera to Human Apo B - K860894 Dade Behring Apolipoprotein Standard Serum - K041870… | 1986 |
| * | K041870 | N Apolipoprotein Standard SerumSummary page 1…Dade Behring N Antisera to Human Apo A-1 - K860894 Dade Behring N Antisera to Human Apo B - K860894 Dade Behring Apolipoprotein Standard Serum - K041870 Dade Behring Apolipoprotein Control Serum CHD - K993310 4. Device Description: Dimension Vista'Tm… | 2004 |
| * | K993310 | Apolipoprotein Control Serum CHD, Model OuphSummary page 1…Dade Behring N Antisera to Human Apo B - K860894 Dade Behring Apolipoprotein Standard Serum - K041870 Dade Behring Apolipoprotein Control Serum CHD - K993310 4. Device Description: Dimension Vista'Tm APOAI and APOB Flex® reagent cartridges: Proteins contained… | 1999 |
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 |
|---|---|---|---|
| K181373 | Extended Lipid Panel Assay | 2018 | 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 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K181373 (Laboratory Corporation of America Holdings, 2018) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K860894.
How does its category compare?
All MSJ devicesMSJ Apolipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MSJ
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MSJ
Too few MSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MSJ
No recall names MSJ since 2007.
Adverse event reports per year · MSJ
No MAUDE report names MSJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-I in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. The APOB method is an in vitro diagnostic test for the quantitative…
Read the full statement (172 words)
The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-I in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Apolipoprotein Calibrator is an in vitro diagnostic product for the calibration of the Apolipoprotein A-I (APOAI) and Apolipoprotein B (APOB) methods on the Dimension Vista® System.
Apolipoprotein Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063608: Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063608
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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