510(k) · Cleared
ClearedAudit MicroControls Linearity FD Tumor Markers II
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 Mar 10, 2017 as substantially equivalent to K130762 (Aalto Scientific, Ltd., 2013) after a 78-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Mar 10, 2017
- Review
- 78 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910440 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK910440 Document Reflectance II Linearity Test SetCasco Standards · 1991
- 4 generations backK023410 Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003
- 3 generations backK042318 Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004
- 2 generations backK082714 Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5Aalto Scientific, Ltd. · 2008
- 1 generation backK130762 Audit Microcv Therapeutic Drug (TDM) Linearity SetAalto Scientific, Ltd. · 2013
- This deviceK163629 Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910440 | Document Reflectance II Linearity Test Set | Casco Standards | 1991 | — |
| −4 | K023410 | Validate Chem 10 Calibration Verification Test Set, Model 110 | Maine Standards Co. | 2003 | — |
| −3 | K042318 | Audit Microcv General Chemistry Linearity Set | Aalto Scientific, Ltd. | 2004 | — |
| −2 | K082714 | Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5 | Aalto Scientific, Ltd. | 2008 | — |
| −1 | K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity Set | Aalto Scientific, Ltd. | 2013 | — |
| 0 (this device) | K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity SetSummary page 4…e Classification: Class I, Reserved Product Code: JJY Regulation Number: 21CFR862.1660 C. Device to Which Substantial Equivalence is Claimed K130762: Audit ® MicroCV ™ Therapeutic Drug (TDM) Linearity Set D. Intended Use The Audit® MicroControls™ Linearity FD Tumor Markers… | 2013 |
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 26 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K130762.
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. 2017, 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® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration verification, and the verification of reportable range for the HE4 and HER2 analytes.
The Audit® MicroControls™ Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163629: Audit MicroControls Linearity FD Tumor Markers II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163629
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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