510(k) · Cleared
ClearedQuanta Flash Acl Lga, Quanta Flash B2GP1 Iga
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Feb 26, 2013 after a 344-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Feb 26, 2013
- Review
- 344 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK120817 Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaInova Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK243979 Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K243979Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 Iga | Inova Diagnostics, Inc. | 2013 | — |
| +1 | K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 MID? 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 MID device
- #1 K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagentscore 8.8 · 2 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | 2026 | 0 |
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, K243979 (Inova Diagnostics, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MID
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MID
234in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MID
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MID
1in 2023
MAUDE reports naming product code MID, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 234 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings. The QUANTA Flash aCL IgA Controls are intended for quality…
Read the full statement (153 words)
QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings.
The QUANTA Flash aCL IgA Controls are intended for quality contro! purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument.
Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 (32GP1) IgA anlibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings.
The QUANTA Flash $2GP1 IgA Controls are intended for the quality confrol purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.
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/K120817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120817: Quanta Flash Acl Lga, Quanta Flash B2GP1 Iga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120817
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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