510(k) · Cleared

Recalled · Class II · 2018

Tina-Quant Apolipoprotein Ver.2

K013249510(k) TraditionalCleared Nov 16, 200149-day reviewClass II21 CFR 866.5580Recalls 1

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

Roche Diagnostics Corp. · DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control

Cleared on Nov 16, 2001 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 49-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.

Decided: Nov 16, 2001
Review: 49 days
Class: Class II
Product code: DER
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K860894 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
This deviceK013249 Tina-Quant Apolipoprotein Ver.2Roche Diagnostics Corp. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860894	Behring Nephelometer System	Behring Diagnostics, Inc.	1986	—
0 (this device)	K013249	Tina-Quant Apolipoprotein Ver.2	Roche Diagnostics Corp.	2001	—

FIG. 1 — Lineage of K013249, 1986–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DER? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K860894	Behring Nephelometer System Summary page 2 …lent to other devices legally marketed in the United States. We claim equivalence to the Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay (K860894). The following table compares the Tina-quant Apolipoprotein A-1 ver.2 Assay with the predicate device. Feature Tina-quant Apol…	Behring Diagnostics, Inc.	1986	—

Also cleared against K860894: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 14, 2018	Class II	Z-1124-2019	Device Design	COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
16 other devices also cite its predicate K860894.

How does its category compare?

All DER devices

DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DER

FDA has decided no DER device since 2007.

Median 510(k) review, days · DER

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

Recalls per year · DER

No recall names DER since 2007.

Adverse event reports per year · DER

2in 2024

2007high 2 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	1
2024	—	2
2025	—	0
2026	—	—

What is it indicated for?

Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 in human serum and plasma on automated clinical chemistry analyzers.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

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

https://510kreport.com/device/K013249 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013249: Tina-Quant Apolipoprotein Ver.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013249

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026