510(k) · Cleared
Recalled · Class III · 2014Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · JKR Radioimmunoassay, Calcitonin
Cleared on Dec 9, 2002 as substantially equivalent to K964635 (Nichols Institute Diagnostics, 1997) after a 67-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 9, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- JKR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964635 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964635 Nichols Advantage Chemiluminescence Calcitonin KitNichols Institute Diagnostics · 1997
- This deviceK023304 Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000…Diagnostic Products Corp. · 2002
- Descendant · cites it directly · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 2 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK182012 ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018
Most influential descendants
Showing 3 of 3 · See all- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · cites it directly2descendants
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 2 generations on0descendants
- K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964635 | Nichols Advantage Chemiluminescence Calcitonin Kit | Nichols Institute Diagnostics | 1997 | — |
| 0 (this device) | K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin… | Diagnostic Products Corp. | 2002 | — |
| +1 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +2 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +2 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 JKR? 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 JKR device
- #1 K252431 Elecsys Calcitoninscore 13.9 · 10 generations · no Class I recall
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 |
|---|---|---|---|
| * | K964635 | Nichols Advantage Chemiluminescence Calcitonin KitSummary page 2…t Registration #: DPC's establishment Registration No. is 201 71 83 Substantially Equivalent Predicate Device: Nichols Advantagem Calcitonin (K96463 5 ) Descriution of Device: IMMULITE/IMMULITE 1000 Calcitonin and MMULITE 2000 Calcitonin are… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2014 | Class III | Z-0212-2015 | Error in labeling | A typographical error regarding the expiration date was identified in the control module instructions for use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K132828 (Roche Diagnostics, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JKR devicesJKR Radioimmunoassay, Calcitonin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKR
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JKR
Too few JKR 510(k)s in any year since 2007 to give a median.
Recalls per year · JKR
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKR
1in 2025
MAUDE reports naming product code JKR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
IMMULITE/IMMULITE 1000 Calcitonin
For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism
IMMULITE 2000 Calcitonin
For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023304: Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023304
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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