510(k) Report

510(k) · Cleared

Cleared

Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge

K983849510(k) TraditionalCleared Jan 11, 199973-day reviewClass I21 CFR 862.1475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · JHM Colorimetric Method, Lipoproteins

Cleared on Jan 11, 1999 after a 73-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Jan 11, 1999
Review
73 days
Class
Class I
Product code
JHM
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2008: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
  2. Descendant · cites it directly · 5 of its ownK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
  3. Descendant · 2 generations on · 2 of its ownK042006 Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK073072 Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 2008 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK120609 Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK081300 Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12008: 22012: 1
2003high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K032798Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48ADade Behring, Inc. · 2003 · cites it directly5descendants
  • K042006Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Ortho-Clinical Diagnostics, Inc. · 2004 · 2 generations on2descendants
  • K073072Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 2008 · 2 generations on1descendant
  • K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 2012 · 3 generations on0descendants
  • K081300Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983849Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent…Dade Behring, Inc.1999—
+1K032798Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)…Dade Behring, Inc.2003—
+2K042006Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator…Ortho-Clinical Diagnostics, Inc.20043
+2K073072Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc.20082
+3K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc.20121
+3K081300Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics20082

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200820
201210
FIG. 1 — Lineage of K983849, 1999–2012Source: 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—Dimension® High Density Lipoprotein Cholesterol (HDL) Assay
Named without a submission number
—

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032798Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48ADade Behring, Inc.20035

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?

  • Of its descendants, K032798 (Dade Behring, Inc., 2003) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JHM devices

JHM Colorimetric Method, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHM

1in 2012

2008: 22012: 1
2007high 2 (2008) · low 0 (2007)2026

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

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—10
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in JHM

The JHM category page

  • K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc. · 2012
  • K081300Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 20082 recalls
  • K073072Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 20082 recalls
  • K032798Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48ADade Behring, Inc. · 2003
  • K022519LDL Cholesterol (Automated)Jas Diagnostics, Inc. · 20021 recall

https://510kreport.com/device/K983849 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983849: Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983849

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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