510(k) · Cleared
ClearedMulti-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verichem Laboratories, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Mar 28, 2012 as substantially equivalent to K023268 (Phoenix Diagnostics, Inc., 2002) and 2 other predicates after a 182-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Mar 28, 2012
- Review
- 182 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K875285 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK875285 Multi-Chemistry Linearity StandardVerichem Laboratories, Inc. · 1988
- This deviceK112834 Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine…Verichem Laboratories, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875285 | Multi-Chemistry Linearity Standard | Verichem Laboratories, Inc. | 1988 | — |
| 0 (this device) | K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand… | Verichem Laboratories, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K023268 | Phoenix Ise Standard a,B and C for Roche/Avl SystemsSummary page 3…Predicate Device 510k Cleared Date I Carbon Dioxide Standard Kit pHoenix Diagnostics [SE Standards K023268 November 15,… | 2002 |
| * | K875285 | Multi-Chemistry Linearity StandardSummary page 3…2002 2 Urine Chemistry Standard Kit Multi-Chemistry Linearity Standard K875285 Sept. 2,1988 3 Urine Uric Acid Standard Kit Beckman - Syncbron Multi-Calibrator KI110251… | 1988 |
| * | K110251 | Synchron Multi CalibratorSummary page 3…_______________________________2002 5 Cholesterol Standard Kit Beckman - Synchron Multi-Calibrator K1 10251 My 252011 6 Uric Acid Standard Kit Beckman - Synchron Multi-Calibrator K1 10251… | 2011 |
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?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Verichemn ISE Standard Kit is intended for the calibration of sodium, potassium, chloride, lithium, ionized calcium and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Multi-Chemistry Standard Kit is intended for the calibration of sodium, potassium, lactate, chloride, glucose, urea nitrogen…
Read the full statement (408 words)
The Verichemn ISE Standard Kit is intended for the calibration of sodium, potassium, chloride, lithium, ionized calcium and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichem Multi-Chemistry Standard Kit is intended for the calibration of sodium, potassium, lactate, chloride, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium and triglyceride assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichemn Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichemn Urine Chemistry Standard Kit is intended for the calibration of sodium, potassium, chloride, urea nitrogen, creatinine, calcium, phosphorus and magnesium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichemn Urine Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichemn Cholesterol Standard Kit is intended for the calibration of total cholesterol assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichemn Carbon Dioxide Standard Kit is intended for the calibration of carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For/in vitro diagnostic use only.
The Verichemn Electrolyte Standard Kit is intended for the calibration of sodium, potassium, lithium, chloride and ionized calcium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
The Verichemn ISE Standard (S4) is intended for the calibration of sodium, potassium, chloride and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112834: Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112834
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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