510(k) · Cleared
ClearedIL Test Contril Spectrum (Levels 1, 2 and 3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JJS Controls For Blood-Gases, (Assayed And Unassayed)
Cleared on Aug 19, 1997 as substantially equivalent to K963800 (Instrumentation Laboratory CO, 1996) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Aug 19, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- JJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801848 (1980). 6 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 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −1 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| 0 (this device) | K972861 | IL Test Contril Spectrum (Levels 1, 2 and 3) | Instrumentation Laboratory CO | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 JJS? 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 |
|---|---|---|---|
| * | K963800 | IL SynthesisSummary page 1…ed and Unassayed) Class I 7531S Controls for Blood-Gases (Assayed and Unassayed) 751JR Electrolyte Controls (Assayed and Unassayed) Identification of predicate devices: K963800 IL Test™ ContrIL PLUS for monitoring pH/pCO2/pO2/Na+/K+/Ca++/Cl-/Glucose K945677 IL Test™ Multi-4 (Levels 1, 2 and 4) for monit… | 1996 |
| * | K945677 | IL682, CO-OximeterSummary page 1…51JR Electrolyte Controls (Assayed and Unassayed) Identification of predicate devices: K963800 IL Test™ ContrIL PLUS for monitoring pH/pCO2/pO2/Na+/K+/Ca++/Cl-/Glucose K945677 IL Test™ Multi-4 (Levels 1, 2 and 4) for monitoring THb/O2Hb/COHb/MetHb/RHb Description of the device/intended use(s): IL Test… | 1995 |
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 16.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K963800.
How does its category compare?
All JJS devicesJJS Controls For Blood-Gases, (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JJS
Too few JJS 510(k)s in any year since 2007 to give a median.
Recalls per year · JJS
No recall names JJS since 2007.
Adverse event reports per year · JJS
1in 2018
MAUDE reports naming product code JJS, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with
specific concentrations of carbon dioxide and oxygen and with a known level of sodium,
potassium, calcium, chloride and glucose and available in three levels to simulate clinically
significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The
following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/
K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972861 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972861: IL Test Contril Spectrum (Levels 1, 2 and 3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972861
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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