510(k) · Cleared
ClearedAudit Microcv Cardiac Markers Linearity Set
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 Jan 10, 2011 as substantially equivalent to K042318 (Aalto Scientific, Ltd., 2004) after a 122-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jan 10, 2011
- Review
- 122 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910440 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK910440 Document Reflectance II Linearity Test SetCasco Standards · 1991
- 2 generations backK023410 Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003
- 1 generation backK042318 Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004
- This deviceK102617 Audit Microcv Cardiac Markers Linearity SetAalto Scientific, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910440 | Document Reflectance II Linearity Test Set | Casco Standards | 1991 | — |
| −2 | K023410 | Validate Chem 10 Calibration Verification Test Set, Model 110 | Maine Standards Co. | 2003 | — |
| −1 | K042318 | Audit Microcv General Chemistry Linearity Set | Aalto Scientific, Ltd. | 2004 | — |
| 0 (this device) | K102617 | Audit Microcv Cardiac Markers Linearity Set | Aalto Scientific, Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K042318 | Audit Microcv General Chemistry Linearity SetSummary page 1…Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318 Page 3 of 28 AaWtSflt.k flit… | 2004 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
- 11 other devices also cite its predicate K042318.
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. 2011, 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 AuditTM MicroCVTM Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB, Myoglobin, and Troponin I (TnI) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When AuditTM MicroCVTM Cardiac Markers Linearity Set is used for quality control purposes, it is recommended that each laboratory establish its own…
Read the full statement (109 words)
The AuditTM MicroCVTM Cardiac Markers Linearity Set is an assayed quality control material consisting
of five levels human based serum. Each level contains CKMB, Myoglobin, and Troponin I (TnI) analytes.
The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes.
When AuditTM MicroCVTM Cardiac Markers Linearity Set is used for quality control purposes, it is
recommended that each laboratory establish its own means and acceptable ranges and use the values
provided only as guides. The product is intended for use with quantitative assays on the analyzers
indicated in the labeling. The AuditTM Cardiac Markers Linearity Set is "For In Vitro Diagnostic Use
Only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102617: Audit Microcv Cardiac Markers Linearity Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102617
Report an extraction error
Are you the manufacturer?
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