510(k) · Cleared
ClearedAudit Microcv Tumor Markers Linearity Set, Model K719M-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 Oct 30, 2008 as substantially equivalent to K042318 (Aalto Scientific, Ltd., 2004) after a 43-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Oct 30, 2008
- Review
- 43 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910440 (1991). 1 later device descends from it, 1 citing it directly.
- 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 deviceK082717 Audit Microcv Tumor Markers Linearity Set, Model K719M-5Aalto Scientific, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK143573 Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143573Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2015 · cites it directly0descendants
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) | K082717 | Audit Microcv Tumor Markers Linearity Set, Model K719M-5 | Aalto Scientific, Ltd. | 2008 | — |
| +1 | K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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…JJY E. Device to Which Substantial Equivalence is Claimed AuditTM MicroCVTM General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318 Page 3 of 17 A 4alto Scientific, Li… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | 2015 | 0 |
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 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143573 (Aalto Scientific, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 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. 2008, 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 Tumor Markers Linearity Set consists of five levels in Human based serum. Each level contains the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Prostate specific antigen-free (free PSA), total PSA. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product may be used for proficiency testing in interlaboratory surveys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082717: Audit Microcv Tumor Markers Linearity Set, Model K719M-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082717
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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