510(k) · Cleared
Recalled · Class II · 2018Immulite 2000 Folic Acid, Model L2KF02, L2KF06
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CGN Acid, Folic, Radioimmunoassay
Cleared on Nov 12, 1999 as substantially equivalent to K943705 (Diagnostic Products Corp., 1994) after a 45-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 12, 1999
- Review
- 45 days
- Class
- Class II
- Product code
- CGN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943705 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK943705 Folic AcidDiagnostic Products Corp. · 1994 · Recalled
- This deviceK993254 Immulite 2000 Folic Acid, Model L2KF02, L2KF06Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 0 of its ownK060929 Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test…Diagnostic Products Corporation · 2006
Most influential descendants
Showing 1 of 1 · See all- K060929Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic…Diagnostic Products Corporation · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943705 | Folic Acid | Diagnostic Products Corp. | 1994 | 1 |
| 0 (this device) | K993254 | Immulite 2000 Folic Acid, Model L2KF02, L2KF06 | Diagnostic Products Corp. | 1999 | — |
| +1 | K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500… | Diagnostic Products Corporation | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 CGN? 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 CGN device
- #1 K233060 Elecsys Folate IIIscore 9.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K943705 | Folic AcidSummary page 1…(862.1295, 7SCGN) Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 DPC's Registration # is 2017183 DPC’s IMMULITE " Folic Acid (K943705) IMMULITE® 2000 Folic Acid is a clinical device for use with the IMI\/IULITE® 2000 Automated Immunoassay Analyzer. === Page 2… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic… | 2006 | 0 |
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-1676-2018 | 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?
- Its one ancestor has a recall.
- Of its descendants, K060929 (Diagnostic Products Corporation, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGN
Too few CGN 510(k)s in any year since 2007 to give a median.
Recalls per year · CGN
3in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGN
9in 2025
MAUDE reports naming product code CGN, 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 | — | 2 | 26 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 28 |
| 2012 | 0 | — | 2 | 11 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 2 | 2 |
| 2019 | 0 | — | 3 | 1 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IMMULITE 2000 Folic Acid is for in vitro diagnostic use with the IMMULITE 2000 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993254 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993254: Immulite 2000 Folic Acid, Model L2KF02, L2KF06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993254
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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