510(k) · Cleared
ClearedImmulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200 Test,L5KFO6-6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corporation · CDD Radioassay, Vitamin B12
Cleared on Apr 28, 2006 as substantially equivalent to K993251 (Diagnostic Products Corp., 1999) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Apr 28, 2006
- Review
- 23 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943705 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK943705 Folic AcidDiagnostic Products Corp. · 1994 · Recalled
- 1 generation backK993254 Immulite 2000 Folic Acid, Model L2KF02, L2KF06Diagnostic Products Corp. · 1999 · Recalled
- This deviceK060929 Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test…Diagnostic Products Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943705 | Folic Acid | Diagnostic Products Corp. | 1994 | 1 |
| −1 | K993254 | Immulite 2000 Folic Acid, Model L2KF02, L2KF06 | Diagnostic Products Corp. | 1999 | 1 |
| 0 (this device) | K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500… | Diagnostic Products Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K993251 | Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6Summary page 2…nia 90045-6900 Registration #: 3005250747 Substantially Equivalent Predicate Device: IMMULITE 2000 Vitamin B 12 (K993251) Description of Device: IMMULITE 2500 Vitamin B 12 is a solid-phase, two-site… | 1999 |
| * | K993254 | Immulite 2000 Folic Acid, Model L2KF02, L2KF06Summary page 4…ornia 90045-6900 Registration #: 3005250747 Substantially Equivalent Predicate Device: IMMULITE 2000 Folic Acid (K993254) Description of Device: IMMULITE 2500 Folic Acid is a solid-phase, two-site c… | 1999 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 3 ancestors have a recall of any class.
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?
The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060929: Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200 Test,L5KFO6-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060929
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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