510(k) · Cleared
ClearedImmulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration
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 Oct 22, 2013 as substantially equivalent to K092168 (Roche Diagnostics, 2009) and 3 other predicates after a 22-day review. Its family tree reaches back 5 generations to 1995. 13 later devices descend from it.
- Decided
- Oct 22, 2013
- Review
- 22 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K950469 (1995). 15 ancestors in all, the oldest K910440 (1991). 13 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 4 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 3 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 2 generations backK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
- 1 generation backK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
- This deviceK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK140541 Immulite 2000: C-Peptide Calibration Verification Material, SHBG…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK141444 Immulite 2000; Cortisol Calibration Verification Material, Folic…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK143687 ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly7descendants
- K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly3descendants
- K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly2descendants
- K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on1descendant
- K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −4 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −3 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −2 | K102904 | Enhanced Estradiol (EE2) Master Curve Material | Siemens Healthcare Diagnostics | 2010 | — |
| −1 | K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification Material | Siemens Healthcare Diagnostics | 2011 | — |
| 0 (this device) | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +1 | K140258 | Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K140541 | Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K141444 | Immulite 2000; Cortisol Calibration Verification Material, Folic Acid… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 8 | 0 |
| 2015 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K092168 | Elecsys HCG+B Calcheck 5Summary page 1…Unassayed) Panel: Clinical Chemistry (75) 3. Predicate Device Name Eleesys HCG CalCheck 5 Predicate 510(k) No: K092 168 4. Device Description: The Calibration Verification Material (CVM) contains One set of four… | 2009 |
| * | K101075 | Elecsys Insulin Calcheck 5Summary page 7…and Unassayed) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys Insulin CalCheck 5 Predicate 510(k) No: K101075 4. Device Description: The Calibration Verification Material (CVM) contains one set of four… | 2010 |
| * | K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSummary page 12…te Device Name IMMULITE® Unconjugated Estriol (uE3) Calibration Verification Material (CVM) Predicate 510(k) No: K 110061 4. Device Description: The Calibration Verification Material (CVM) contains one set of… | 2011 |
| * | K100715 | Audit Microcv Homocysteine Linearity Set, Model 704M-5Summary page 17…ts Code: Clinical Chemistry (75) Panel: 3. Predicate Device Name AuditTM MicroCVTM Homocysteine Linearity Set Predicate 510(k) No: K100715 4. Device Description: The Calibration Verification Material (CVM) contains one set of four… | 2010 |
What descends from it? (13)
See all 137 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140258 | Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification… | 2014 | 7 |
| K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration… | 2014 | 3 |
| K140541 | Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration… | 2014 | 2 |
| K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3… | 2014 | 0 |
| K142878 | IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High… | 2014 | 0 |
| K142811 | IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3… | 2014 | 0 |
| K141772 | Immulte 2000 Rubella Quantitative Igg Calibration Verification Material | 2014 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K140258 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K092168.
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. 2013, 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® HCG Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE HCG assay on the IMMULITE 2000 systems. The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems. The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro…
Read the full statement (143 words)
The IMMULITE® HCG Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE HCG assay on the IMMULITE 2000 systems.
The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems.
The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Pyrilinks-D assay on the IMMULITE 2000 systems.
The IMMULITE® Homocysteine Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Homocysteine assay on the IMMULITE 2000 systems.
The IMMULITE® Growth Hormone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Growth Hormone assay on the IMMULITE 2000 systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133128
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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