510(k) · Cleared
ClearedA/C Enzymatic Vitamin B6 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anticancer, Inc. · CDD Radioassay, Vitamin B12
Cleared on Jul 26, 2012 as substantially equivalent to K955561 (American Laboratory Products Co., Ltd., 1996) after a 448-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 26, 2012
- Review
- 448 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955561 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955561 Buhlmann Vitamin B6 ReaAmerican Laboratory Products Co., Ltd. · 1996
- This deviceK111260 A/C Enzymatic Vitamin B6 AssayAnticancer, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955561 | Buhlmann Vitamin B6 Rea | American Laboratory Products Co., Ltd. | 1996 | — |
| 0 (this device) | K111260 | A/C Enzymatic Vitamin B6 Assay | Anticancer, Inc. | 2012 | — |
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 CDD? 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 CDD device
- #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K955561 | Buhlmann Vitamin B6 ReaSummary page 2…amin B6 REA American Laboratory Products CO., LTD PO BOX 4511 Windham, NH 03087 Tel: (603) 893-8914 (2) Predicate 5 10(k) number K955 561 4. Information of Manufacturer Manufacturer: Bioserv Corporation 5340 Eastgate Mall San D… | 1996 |
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.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CDD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDD
147in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDD
44in 2025
MAUDE reports naming product code CDD, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 36 |
| 2012 | 3 | 147 | 0 | 23 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 2 | 15 |
| 2019 | 2 | — | 1 | 14 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 28 |
| 2022 | 1 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative determination of pyridoxal 5'-phosphate (PLP, vitamin B36) in EDTA-plasma.
The device will monitor vitamin 86 (PLP) status in human plasma for aid in diagnosis of vitamin 86 deficiency.
The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111260: A/C Enzymatic Vitamin B6 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111260
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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