510(k) Report

510(k) · Cleared

Cleared

Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent

K984303510(k) TraditionalCleared Jan 28, 199957-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

Ortho-Clinical Diagnostics, Inc. · LBR Ldl & Vldl Precipitation, Hdl

Cleared on Jan 28, 1999 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Jan 28, 1999
Review
57 days
Class
Class I
Product code
LBR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2007: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK984303 Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentOrtho-Clinical Diagnostics, Inc. · 1999
  2. Descendant · cites it directly · 5 of its ownK012593 Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros…Ortho-Clinical Diagnostics, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK071801 Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S)…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK073157 Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  5. Descendant · 4 generations on · 2 of its ownK081411 Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
  6. Descendant · 5 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001: 12007: 22008: 12009: 12010: 1
2001high 2 (2007) · low 0 (2002)2026

Most influential descendants

Showing 5 of 6 · See all
  • K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2001 · cites it directly5descendants
  • K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc. · 2007 · 2 generations on4descendants
  • K073157Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · 3 generations on3descendants
  • K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2008 · 4 generations on2descendants
  • K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K984303Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentOrtho-Clinical Diagnostics, Inc.1999—
+1K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry…Ortho-Clinical Diagnostics, Inc.20011
+2K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207…Ortho-Clinical Diagnostics, Inc.20074
+3K073157Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.20071
+4K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.20084
+5K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator…Ortho-Clinical Diagnostics, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200720
200810
200910
201010
FIG. 1 — Lineage of K984303, 1999–2010Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LBR? 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.20015

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, K012593 (Ortho-Clinical Diagnostics, Inc., 2001) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LBR devices

LBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBR

1in 2015

2008: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBR

Too few LBR 510(k)s in any year since 2007 to give a median.

Recalls per year · LBR

1in 2018

2009: 42016: 12018: 1
2007high 4 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LBR

8in 2025

2007: 12008: 12011: 12012: 12016: 12019: 22021: 12022: 22023: 22024: 12025: 8
2007high 8 (2025) · low 0 (2009)2025

MAUDE reports naming product code LBR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20081—01
20090—40
20100—00
20110—01
20120—01
20130—00
20140—00
20151—00
20160—11
20170—00
20180—10
20190—02
20200—00
20210—01
20220—02
20230—02
20240—01
20250—08
20260—0—

What is it indicated for?

For in vitro diagnostic use only.

The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Ortho-Clinical Diagnostics, Inc.

273 FDA decisions under this applicant name. See the company

  • K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
  • DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • P090028/S018VITROS Immunodiagnostic Products HBeAg Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc. · 2023
  • P030026/S037VITROS Anti-HBc IgMOrtho-Clinical Diagnostics, Inc. · 2023

Recent decisions in LBR

The LBR category page

  • K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo) · 2015
  • K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics · 2008
  • K050823Direct HDL Cholesterol and Direct HDL/LDL CalibratorTeco Diagnostics · 2005
  • K023784Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerHemagen Diagnostics, Inc. · 2002
  • K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 20011 recall

https://510kreport.com/device/K984303 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984303: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984303

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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