510(k) Report

510(k) · Cleared

Cleared

Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator Kits

K013152510(k) TraditionalCleared Nov 9, 200150-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

Elan Holdings, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Cleared on Nov 9, 2001 after a 50-day review. The FDA summary names its predicate without a number.

Decided
Nov 9, 2001
Review
50 days
Class
Class I
Product code
LBS
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K013152Source: FDA 510(k) database · 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 LBS? 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? (2)

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
*—Roche HDL-Cholesterol plus Reagent Kit, product no. 1930672
Named without a submission number
—
*—Roche C.f.a.s HDL/LDL-C plus calibrator, product no. 1972235
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LBS devices

LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBS

2in 2016

2007: 22008: 32010: 22011: 32012: 12014: 12016: 2
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBS

118in 2011

2008: 129 days median2011: 118 days median
2007high 129 (2008) · low 118 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LBS

1in 2013

2008: 12012: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LBS

6in 2025

2010: 22011: 32016: 12017: 42019: 22020: 12021: 12022: 22023: 52024: 22025: 6
2007high 6 (2025) · low 0 (2007)2025

MAUDE reports naming product code LBS, 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
20072—00
2008312910
20090—00
20102—02
2011311803
20121—10
20130—10
20141—00
20150—00
20162—01
20170—04
20180—00
20190—02
20200—01
20210—01
20220—02
20230—05
20240—02
20250—06
20260—0—

What is it indicated for?

The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (suchras diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

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

More from Elan Holdings, Inc.

12 FDA decisions under this applicant name. See the company

  • K012474Atac Pak CPK Reagent KitElan Holdings, Inc. · 2001
  • K010488Atac Pak Ast Reagent KitElan Holdings, Inc. · 2001
  • K000958Atac Pak Bun Reagent and Atac Calibrator KitsElan Holdings, Inc. · 2000
  • K000900Atac Pak Cholesterol Reagent and Atac Callibrator KitsElan Holdings, Inc. · 2000
  • K992844Hichem Ise Electrolyte BufferElan Holdings, Inc. · 1999

Recent decisions in LBS

The LBS category page

  • K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo) · 2016
  • K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd. · 2016
  • K132711Carolina Liquid Chemistries HDL Cholesterol ReagentCarolina Liquid Chemistries Corp. · 2014
  • K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 20121 recall
  • K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011

https://510kreport.com/device/K013152 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013152: Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013152

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026