510(k) · Cleared
ClearedBioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets
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 Mar 30, 2012 as substantially equivalent to K022992 (Corgenix, Inc., 2002) and 3 other predicates after a 456-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Mar 30, 2012
- Review
- 456 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K013080 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK013080 Reaads Anti-Beta 2 Glycoprotein I Igg Test KitCorgenix, Inc. · 2001
- This deviceK103834 Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsBio-Rad Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013080 | Reaads Anti-Beta 2 Glycoprotein I Igg Test Kit | Corgenix, Inc. | 2001 | — |
| 0 (this device) | K103834 | Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets | Bio-Rad Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001Summary page 2…Quality control Material unassayed) (JJX) ________ (Assayed and Unassayed) 4. Predicate Devices K022992 REAADS anti-Cardiolipin IgG/lgM Semi -Quantitative Test Kit (2 assays) K022990 REAADS IgA anti-Cardiolipin Semi-Quantitative Test… | 2002 |
| * | K022990 | Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001Summary page 2…________ (Assayed and Unassayed) 4. Predicate Devices K022992 REAADS anti-Cardiolipin IgG/lgM Semi -Quantitative Test Kit (2 assays) K022990 REAADS IgA anti-Cardiolipin Semi-Quantitative Test Kit KO013080 REAADS anti-Beta 2 Glycoprotein I IgO Test Kit KO013 079 REAADS a… | 2002 |
| * | K013080 | Reaads Anti-Beta 2 Glycoprotein I Igg Test KitSummary page 7…s Test Kits Materials (K021992 IgG, K022990 (K013080, K013077,, IgA)… | 2001 |
| * | K013079 | Reaads Anti-Beta 2 Glycoprotein I Iga Test KitSummary page 6…s (K022992 .IgG, K022990 (KOi3080, K013077, ______________ gA) K013079) ntended Use The BioPlex 2200 APLS An enzyme-linked An enzyme-linked… | 2001 |
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?
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K022992.
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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® 2200 APLS IgG and IgA kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (β2GP1) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus…
Read the full statement (190 words)
The BioPlex® 2200 APLS IgG and IgA kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (β2GP1) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.
The BioPlex 2200 APLS IgG and IgA kits are intended for use with the Bio-Rad BioPlex 2200 System
The BioPlex® 2200 APLS IgG and IgA Calibrator Sets are intended for the calibration of the corresponding BioPlex 2200 APLS IgG and IgA Reagent Packs.
The BioPlex® 2200 APLS IgG and IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and the corresponding BioPlex 2200 APLS IgG and IgA Reagent Packs in the clinical laboratory. The performance of the BioPlex 2200 APLS IgG and IgA Control Sets has not been established with any other anti-Cardiolipin and anti-Beta-2 Glycoprotein I IgG or IgA APS assays.
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/K103834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103834: Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103834
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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