510(k) · Cleared

Cleared

Tina-Quant Apolipoprotein a-1 Ver.2

K013278510(k) TraditionalCleared Nov 15, 200145-day reviewClass I21 CFR 866.5590

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

Roche Diagnostics Corp. · DEL Lipoprotein X, Antigen, Antiserum, Control

Cleared on Nov 15, 2001 as substantially equivalent to K990594 (Roche Diagnostics Corp., 1999) after a 45-day review. Its family tree reaches back 2 generations to 1996.

Decided: Nov 15, 2001
Review: 45 days
Class: Class I
Product code: DEL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K954992 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK954992 Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1996
1 generation backK990594 Integra Reagent Cassette for Apolipoprotein a-1Roche Diagnostics Corp. · 1999
This deviceK013278 Tina-Quant Apolipoprotein a-1 Ver.2Roche Diagnostics Corp. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954992	Roche Cobas Integra Reagent Cassettes	Roche Diagnostic Systems, Inc.	1996	—
−1	K990594	Integra Reagent Cassette for Apolipoprotein a-1	Roche Diagnostics Corp.	1999	—
0 (this device)	K013278	Tina-Quant Apolipoprotein a-1 Ver.2	Roche Diagnostics Corp.	2001	—

FIG. 1 — Lineage of K013278, 1996–2001Source: 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 DEL? 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
*	K990594	Integra Reagent Cassette for Apolipoprotein a-1 Summary page 2 …in A-1 ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the COBAS Integra Tina-quant Apolipoprotein A-1 (K990594). The following table compares the Tina-quant Apolipoprotein A-1 ver.2 Assay with the predicate device. Feature Tina-quant Apol…	Roche Diagnostics Corp.	1999	—

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.

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All DEL devices

DEL Lipoprotein X, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEL

FDA has decided no DEL device since 2007.

Median 510(k) review, days · DEL

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

Recalls per year · DEL

No recall names DEL since 2007.

Adverse event reports per year · DEL

No MAUDE report names DEL since 2007.

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	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma.

For the quantitative determination of apolipoprotein A-1 in serum and plasma. 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/K013278 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013278: Tina-Quant Apolipoprotein a-1 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/K013278

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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