510(k) · Cleared

Cleared

Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1; Controls.

K141274510(k) TraditionalCleared Feb 13, 2015273-day reviewClass II21 CFR 866.5660

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

Inova Diagnostics, Inc. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Cleared on Feb 13, 2015 as substantially equivalent to K970551 (Inova Diagnostics, Inc., 1997) after a 273-day review. Its family tree reaches back 1 generation to 1997.

Decided: Feb 13, 2015
Review: 273 days
Class: Class II
Product code: MSV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970551 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK970551 Quanta Lite B2GPI IggInova Diagnostics, Inc. · 1997
This deviceK141274 Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI…Inova Diagnostics, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970551	Quanta Lite B2GPI Igg	Inova Diagnostics, Inc.	1997	—
0 (this device)	K141274	Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1…	Inova Diagnostics, Inc.	2015	—

FIG. 1 — Lineage of K141274, 1997–2015Source: 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 MSV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MSV device

#1 K243979 Aptiva APS IgA Reagentscore 10.8 · 1 generation · no Class I recall

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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
*	K970551	Quanta Lite B2GPI Igg Summary page 4 …it) Regulation Number 862.1660 (Controls) Device Class 2 Predicate device: QUANTA Lite® β2GPI IgG ELISA, 510(k) number: K970551 1 Device description: The QUANTA Flash® ß2GP1-Domain1 assa…	Inova Diagnostics, Inc.	1997	—

Also cleared against K970551: 3 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
3 other devices also cite its predicate K970551.

How does its category compare?

All MSV devices

MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MSV

1in 2018

2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSV

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

Recalls per year · MSV

No recall names MSV since 2007.

Adverse event reports per year · MSV

No MAUDE report names MSV since 2007.

View these four charts as a table

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

What is it indicated for?

The QUANTA Flash® B2GP1-Domain1 is an in vitro chemiluminescent immunoassay (CIA) for the semi-quantitative determination of IgG autoantibodies to B2GP1-Domain1 in human serum. The presence of anti-B2GP1-Domain1 autoantibodies is used in conjunction with clinical and other laboratory findings as an aid in the diagnosis of antiphospholipid syndrome. The QUANTA Flash® B2GP1-Domain1 is not intended to replace assays for antibodies against the whole B2GP1…

Read the full statement (216 words)

The QUANTA Flash B2GP1-Domain1 Controls are intended for quality control purposes of the QUANTA Flash B2GP1-Domain1 chemiluminescent immunoassay (CIA) kit.

The HemosIL® AcuStar Anti-B2GPI Domain 1 is an in vitro chemiluminescent immunoassay (CIA) for the semi-quantitative determination of IgG autoantibodies to B2GPI Domain 1 in human serum. The presence of anti-B2GPI Domain 1 autoantibodies is used in conjunction with clinical and other laboratory findings as an aid in the diagnosis of antiphospholipid syndrome. The HemosIL® AcuStar Anti-B2GPI Domain 1 is not intended to replace assays for antibodies against the whole B2GPI molecule. Testing for antibodies to the whole B2GPI molecule is required according to the classification criteria for antiphospholipid syndrome.

The HemosIL AcuStar Anti-B2GPI Domain 1 Controls are intended for quality control purposes of the HemosIL AcuStar Anti-B2GPI Domain 1 chemiluminescent immunoassay (CIA) kit.

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/K141274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141274: Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1; Controls..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141274

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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