510(k) · Cleared
ClearedIMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Dec 24, 2014 as substantially equivalent to K133128 (Siemens Healthcare Diagnostics, Inc., 2013) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Dec 24, 2014
- Review
- 30 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K950469 (1995). 24 ancestors in all, the oldest K910440 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 6 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 5 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 4 generations backK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
- 3 generations backK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
- 2 generations backK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- 1 generation backK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
- This deviceK143352 IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE…Siemens Healthcare Diagnostics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −6 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −5 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −4 | K102904 | Enhanced Estradiol (EE2) Master Curve Material | Siemens Healthcare Diagnostics | 2010 | — |
| −3 | K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification Material | Siemens Healthcare Diagnostics | 2011 | — |
| −2 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| −1 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| 0 (this device) | K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Summary page 4…Clinical Chemistry (75) 3. Predicate Device Name: IMMULITE® 2000 HCG Calibration Verification Material (CVM) Predicate 510(k) No: k133128 The Ferritin Calibration Verification Material (CVM) contains one set 4. Device Descriptio… | 2013 |
| * | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Summary page 11…Clinical Chemistry (75) 3. Predicate Device Name IMMULITE® 2000 IGF-1 Calibration Verification Material (CVM) Predicate 510(k) No: K140818 4. Device Description: IMMULITE® 2000 IGFBP-3 Calibration Verification Material (C… | 2014 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 24 ancestors has a recall of any class.
- 6 other devices also cite its predicate K133128.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMULITE® Ferritin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Ferritin assay on the IMMULITE 2000 systems
The IMMULITE® IGFBP-3 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGFBP-3 assay on the IMMULITE 2000 systems
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/K143352 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143352: IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143352
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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