510(k) · Cleared
Recalled · Class II · 2018Immulite Vitamin B12 (LKVB1,LKVB5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CDD Radioassay, Vitamin B12
Cleared on May 16, 1997 as substantially equivalent to K860815 (Diagnostic Products Corp., 1986) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- May 16, 1997
- Review
- 46 days
- Class
- Class II
- Product code
- CDD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K860815 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK860815 Solid Phase Boil Dualcount (Dualcount SPB)Diagnostic Products Corp. · 1986
- This deviceK971177 Immulite Vitamin B12 (LKVB1,LKVB5)Diagnostic Products Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860815 | Solid Phase Boil Dualcount (Dualcount SPB) | Diagnostic Products Corp. | 1986 | — |
| 0 (this device) | K971177 | Immulite Vitamin B12 (LKVB1,LKVB5) | Diagnostic Products Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 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? (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 |
|---|---|---|---|
| * | K860815 | Solid Phase Boil Dualcount (Dualcount SPB)Summary page 1…75CDD) Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 DPC's Registration # is 2017183 DPC's Solid Phase No Boil Dualcount® (K860815); Bio-Rad's Quantaphase |I1® B12/Folate Radioassay (K933315). IMMULITE® Vitamin B12 is a clinical device for use with the IMMUL… | 1986 |
| * | K933315 | Radias B12 Enzyme ImmunoassaySummary page 1…t Los Angeles, California 90045-5597 DPC's Registration # is 2017183 DPC's Solid Phase No Boil Dualcount® (K860815); Bio-Rad's Quantaphase |I1® B12/Folate Radioassay (K933315). IMMULITE® Vitamin B12 is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. IMMULITE® Vitamin B12… | 1993 |
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 |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1686-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
IMMULITE® Vitamin B12 is a chemiluminescent assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative detection of vitamin B12 in human serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in clinical diagnosis and treatment of anemia.
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/K971177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971177: Immulite Vitamin B12 (LKVB1,LKVB5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971177
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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