510(k) · Cleared
Recalled · Class II · 2023Bioplex 2200 Apls Igm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · MID System, Test, Anticardiolipin Immunological
Cleared on Oct 21, 2013 as substantially equivalent to K092181 (Instrumentation Laboratory CO, 2010) and 1 other predicate after a 234-day review. Its family tree reaches back 2 generations to 2002. It has been recalled once.
- Decided
- Oct 21, 2013
- Review
- 234 days
- Class
- Class II
- Product code
- MID
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022992 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK022992 Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model…Corgenix, Inc. · 2002
- 1 generation backK092181 Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO · 2010
- This deviceK130528 Bioplex 2200 Apls IgmBio-Rad Laboratories · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001 | Corgenix, Inc. | 2002 | — |
| −1 | K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls | Instrumentation Laboratory CO | 2010 | — |
| 0 (this device) | K130528 | Bioplex 2200 Apls Igm | Bio-Rad Laboratories | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsSummary page 4…3 Substantial Equivalence Information: 1. Predicate device name(s): HemoslL AcuStar anti-Cardiolipin 1gM. k092 181 HlemoslL AcuStar anti-f32 Glycoprotein-l 1gM. kOS91556 2. Comparison with Predicate:… | 2010 |
| * | K091556 | Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls | 2010 |
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 |
|---|---|---|---|---|
| Feb 28, 2023 | Class II | Z-1572-2023 | Under Investigation by firm | APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K092181.
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?
The BioPlex®i, 2200 Antiphospholipid Syndrome (AILS) IgM kit'is a multiplex flow immunoassay intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CI.) and Beta-2 Glycoprotein I (132G1'I) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (Al'S) and those secondary to…
Read the full statement (170 words)
The BioPlex®i, 2200 Antiphospholipid Syndrome (AILS) IgM kit'is a multiplex flow immunoassay intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CI.) and Beta-2 Glycoprotein I (132G1'I) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (Al'S) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.
The B3iolex 2200 AILS IgMt kit is intended For use with the Bio-Rad BioPlex 2200 System
The IlioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding liiol'Iex 2200 API.S IgM4 Reagent Pack in the clinical laboratory. The performance of the BioI'ex 2200 APILS IgM Control Set has not been established with any other Antiphospholipid assay.
The lBiollex 2200 AILS IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130528: Bioplex 2200 Apls Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130528
Report an extraction error
Are you the manufacturer?
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