510(k) · Cleared
ClearedAudit Microcv Ammonian/Ethanol Linearity Set, Model K712M-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 3, 2010 as substantially equivalent to K944338 (Casco Standards, 1994) after a 175-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 3, 2010
- Review
- 175 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944338 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944338 Document R Ammonia / Ethanol Calibration Verification Rest SetCasco Standards · 1994
- This deviceK100718 Audit Microcv Ammonian/Ethanol Linearity Set, Model K712M-5Aalto Scientific, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944338 | Document R Ammonia / Ethanol Calibration Verification Rest Set | Casco Standards | 1994 | — |
| 0 (this device) | K100718 | Audit Microcv Ammonian/Ethanol Linearity Set, Model K712M-5 | Aalto Scientific, Ltd. | 2010 | — |
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 JJY? 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? (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 |
|---|---|---|---|
| * | K944338 | Document R Ammonia / Ethanol Calibration Verification Rest SetSummary page 1…rade Name: Document Ammonia/Ethanol CAL.VER® Microgenics Corporation, Fremont, Ca K944338 Page 1 of 4 .A~djSoeritle. I liL F. Description of the Device The AuditTM Mic… | 1994 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This…
Read the full statement (109 words)
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material
consisting of five levels protein (bovine) based serum. Each level contains Ammonia and
Ethanol analytes. The five levels demonstrate a linear relationship to each other for
Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples
and to detect systematic analytical deviations of laboratory testing procedures for
Ammonia and Ethanol. This product may be used as unassayed quality control material
for Ammonia and Ethanol analytes. The product is intended for use with quantitative
assays on the indicated analyzer provided in the labeling. The Audit MicroCV
Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100718 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100718: Audit Microcv Ammonian/Ethanol Linearity Set, Model K712M-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100718
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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