510(k) · Cleared
Recalled · Class II · 2017Loci 8 Calibrator, Model KC 646
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jul 9, 2010 as substantially equivalent to K962041 (Ciba Corning Diagnostics Corp., 1996) and 1 other predicate after a 44-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.
- Decided
- Jul 9, 2010
- Review
- 44 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910198 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910198 | Ciba Corning Acs LH Immunoassay | Ciba Corning Diagnostics Corp. | 1991 | — |
| −1 | K962041 | Acs LH2 Immunoassay | Ciba Corning Diagnostics Corp. | 1996 | — |
| 0 (this device) | K101460 | Loci 8 Calibrator, Model KC 646 | Siemens Healthcare Diagnostics | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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 JIX? 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 |
|---|---|---|---|
| * | K962041 | Acs LH2 ImmunoassaySummary page 1…JIX; Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Siemens Calibrator B, k962041 (FSH, LH-, Prolactin) Roche Estradiol 11CalSet II , k992981 (Estradiol) 4. Device Descriptions:… | 1996 |
| * | K992981 | Elecsys Estradiol Calset IISummary page 1…3. Identification of the Legally Marketed Device: Siemens Calibrator B, k962041 (FSH, LH-, Prolactin) Roche Estradiol 11CalSet II , k992981 (Estradiol) 4. Device Descriptions:… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2017 | Class II | Z-1184-2018 | Under Investigation by firm | An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 14.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
LOCI B CAL is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2) methods on the Dimension Vista™ systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101460: Loci 8 Calibrator, Model KC 646.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101460
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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