510(k) · Cleared
Recalled · Class II · 2018Randox Calcium (Ca)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · CJY Azo Dye, Calcium
Cleared on Oct 23, 2018 as substantially equivalent to K083386 (Siemens Healthcare Diagnostics, 2009) after an 85-day review. Its family tree reaches back 2 generations to 1999. It has been recalled once.
- Decided
- Oct 23, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- CJY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991576 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK991576 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- 1 generation backK083386 Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML…Siemens Healthcare Diagnostics · 2009 · Recalled
- This deviceK182042 Randox Calcium (Ca)Randox Laboratories, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 3 |
| −1 | K083386 | Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N… | Siemens Healthcare Diagnostics | 2009 | 1 |
| 0 (this device) | K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | 2018 | — |
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 CJY? 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 CJY device
- #1 K244042 Calcium2score 9.4 · 3 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 |
|---|---|---|---|
| * | K083386 | Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…Summary page 5…NDOX CALCIUM (Ca) 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: ADVIA Chemistry Calcium_2 (CA_2) Method, 510(k) Number: K083386 5. INTENDED USE The Randox Calcium (Ca) device is intended for the quantitative in vitro determination of calcium concentratio… | 2009 |
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 |
|---|---|---|---|---|
| Dec 4, 2018 | Class II | Z-0840-2019 | Device Design | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · CJY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJY
Too few CJY 510(k)s in any year since 2007 to give a median.
Recalls per year · CJY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJY
59in 2025
MAUDE reports naming product code CJY, 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 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 4 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 2 | 21 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination of calcium concentration in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182042: Randox Calcium (Ca).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182042
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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