510(k) · Cleared
ClearedDimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JHM Colorimetric Method, Lipoproteins
Cleared on Oct 30, 2003 as substantially equivalent to K983849 (Dade Behring, Inc., 1999) after a 51-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 51 days
- Class
- Class I
- Product code
- JHM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983849 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
- This deviceK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK042006 Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK073072 Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK120609 Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK081300 Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK052867 Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K042006Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly2descendants
- K073072Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 2008 · cites it directly1descendant
- K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 2012 · 2 generations on0descendants
- K081300Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
- K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)… | Dade Behring, Inc. | 2003 | — |
| +1 | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| +1 | K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48B | Dade Behring, Inc. | 2008 | 2 |
| +2 | K120609 | Vitros Chemistry Products DHDL Slides | Ortho-Clinical Diagnostics, Inc. | 2012 | 1 |
| +2 | K081300 | Dimension Vista HDLC Flex Reagent Cartridge | Siemens Healthcare Diagnostics | 2008 | 2 |
| +2 | K052867 | Vitros Chemistry Products Dtibc Reagent | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 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 JHM? 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 |
|---|---|---|---|
| * | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent CartridgeSummary page 1…on: Class I Product Code: JHM Predicate Device Dimension@Automated HDL Cholesterol (AHDL) Flex@reagent cartridge (DF48) FDA Document Control No. K983849 Device Description The Dimension@Automated HDL Cholesterol (AHDL) Flex@reagent cartridge (DF48A) is an in vitro diagnostic devic… | 1999 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K042006 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JHM devicesJHM Colorimetric Method, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHM
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JHM
Too few JHM 510(k)s in any year since 2007 to give a median.
Recalls per year · JHM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHM
No MAUDE report names JHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 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 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AHDL method for the Dimension clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032798: Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032798
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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