510(k) · Cleared
ClearedGemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Feb 6, 2009 as substantially equivalent to K961458 (Avl Scientific Corp., 1996) and 3 other predicates after a 163-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 163 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K861087 (1986). 7 ancestors in all, the oldest K810615 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 1 generation backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- This deviceK082462 Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK200544 SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK121140 Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −1 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| 0 (this device) | K082462 | Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ | Diamond Diagnostics, Inc. | 2009 | — |
| +1 | K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020 | — |
| +1 | K121140 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K961458 | Avl 9180 Electrolyte AnalyzerSummary page 1…Class 11 JIH (6) Predicate Devices: Description 510O(k) Analytes AVL9180 K961458 Sodium, Potassium, Chloride, Calcium and Lithium IL 943 Flame Photometer K823480 Sodi… | 1996 |
| * | K823480 | IL 943 Flame PhotometerSummary page 1…(k) Analytes AVL9180 K961458 Sodium, Potassium, Chloride, Calcium and Lithium IL 943 Flame Photometer K823480 Sodium, Potassium, Chloride EasyLyte K000926 Sodium, Potassium, Chlori… | 1983 |
| * | K000926 | Easyelectrolyte Analyzer and Rapidlyte AnalyzerSummary page 1…Sodium, Potassium, Chloride, Calcium and Lithium IL 943 Flame Photometer K823480 Sodium, Potassium, Chloride EasyLyte K000926 Sodium, Potassium, Chloride 925 Chloridometer K81 0615 Chloride Statement of Te… | 2000 |
| * | K810615 | Corning 925 Chloride MeterSummary page 1…23480 Sodium, Potassium, Chloride EasyLyte K000926 Sodium, Potassium, Chloride 925 Chloridometer K81 0615 Chloride Statement of Technology Characteristics of the Device Compared to Predicate Device Operating Principl… | 1981 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K200544 (Diamond Diagnostics, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K961458.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples. The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements'obtained by this device are used to monitor electrolyte balance in…
Read the full statement (292 words)
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements'obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance, in the diagnosis 'and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The GemLyte Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intennittent muscular contractions or spasms).
The GemLyte Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082462: Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082462
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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