510(k) · Cleared
ClearedBioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and BI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)
Cleared on Sep 19, 2013 as substantially equivalent to K011566 (Inova Diagnostics, Inc., 2001) and 3 other predicates after a 247-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Sep 19, 2013
- Review
- 247 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K011566 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011566 Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga ElisaInova Diagnostics, Inc. · 2001
- This deviceK130053 Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System…Bio-Rad Laboratories, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011566 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa | Inova Diagnostics, Inc. | 2001 | — |
| 0 (this device) | K130053 | Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200… | Bio-Rad Laboratories, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 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 MVM? 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 MVM device
- #1 K200230 Aptiva Celiac Disease IgG Reagentscore 2.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K011566 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa | 2001 |
| * | K011570 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg ElisaSummary page 4…INOVA QUANTA Lite h-tTG IgO INOVA QUANTA Lite Gliadin IgA 11 INOVA QUANTA Lite Gliadin IgO 11 2. Predicate 5 10(k) number(s): KOI 11566, K01 1570, K052 143, K052142 Page 4 of 21… | 2001 |
| * | K052143 | Quanta Lite Gliadin Iga IISummary page 4…UANTA Lite h-tTG IgO INOVA QUANTA Lite Gliadin IgA 11 INOVA QUANTA Lite Gliadin IgO 11 2. Predicate 5 10(k) number(s): KOI 11566, K01 1570, K052 143, K052142 Page 4 of 21 3. Comp… | 2005 |
| * | K052142 | Quanta Lite Gliadin Igg IISummary page 4…h-tTG IgO INOVA QUANTA Lite Gliadin IgA 11 INOVA QUANTA Lite Gliadin IgO 11 2. Predicate 5 10(k) number(s): KOI 11566, K01 1570, K052 143, K052142 Page 4 of 21 3. Comparison wi… | 2005 |
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 K011566.
How does its category compare?
All MVM devicesMVM Autoantibodies, Endomysial (Tissue Transglutaminase): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MVM
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MVM
275in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVM
No recall names MVM since 2007.
Adverse event reports per year · MVM
1in 2024
MAUDE reports naming product code MVM, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 98 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 275 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immnunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidlated gliadin peptide (DO®) and tissue Transglutaminase (tl'G) in human serum. In conjunction with clinical. findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The lBioPlex 2200 Celiac IgA kit is intended for use with…
Read the full statement (316 words)
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immnunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidlated gliadin peptide (DO®) and tissue Transglutaminase (tl'G) in human serum. In conjunction with clinical. findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy).
The lBioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System.
The SioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Celiac IgA Control Set has not been established with any other anti-tissue Transglutaminase (tTG) and anti-deamidated gliadin peptide IgA assays.
The BioPlex 2200 Celiac IgA Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgA Reagent Pack.
Tlhe BioPlex 2200 Celiac IgO Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the SioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the lBioPlex 2200 Celiac IgO Control Set has not been established with any other anti-tissue Transglutaminase (tTG) and anti-deamidated gliadin peptide IgO assays.
The lBioPlex 2200 Celiac igG Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac Igo Reagent Pack.
The BioPlex 2200 Celiac lgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG aiitoantibhodies to deaniidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy).
The Biorlex 2200 Celiac lgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
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/K130053 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130053: Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and BI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130053
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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