510(k) · Cleared
ClearedAudit Microcv Therapeutic Drug (TDM) 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 Apr 29, 2013 as substantially equivalent to K082714 (Aalto Scientific, Ltd., 2008) after a 40-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 29, 2013
- Review
- 40 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910440 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910440 Document Reflectance II Linearity Test SetCasco Standards · 1991
- 3 generations backK023410 Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003
- 2 generations backK042318 Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004
- 1 generation backK082714 Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5Aalto Scientific, Ltd. · 2008
- This deviceK130762 Audit Microcv Therapeutic Drug (TDM) Linearity SetAalto Scientific, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK163629 Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK161874 Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910440 | Document Reflectance II Linearity Test Set | Casco Standards | 1991 | — |
| −3 | K023410 | Validate Chem 10 Calibration Verification Test Set, Model 110 | Maine Standards Co. | 2003 | — |
| −2 | K042318 | Audit Microcv General Chemistry Linearity Set | Aalto Scientific, Ltd. | 2004 | — |
| −1 | K082714 | Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5 | Aalto Scientific, Ltd. | 2008 | — |
| 0 (this device) | K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity Set | Aalto Scientific, Ltd. | 2013 | — |
| +1 | K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2017 | — |
| +1 | K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K082714 | Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5Summary page 1…ce to Which Substantial Equivalence is Claimed Audit®@ MicroCVTM Therapeutic Drug (TOM) Linearity Set Aalto Scientific, Ltd. Carlsbad, California 510(k) Number: K082714 0. Device Description: The Audit®5 MicroCV Tm Therapeutic Drug (TOM) Linearity Set is an in-vitro diagnostic device consistin… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K163629 (Aalto Scientific, Ltd., 2017) has gone furthest, with 0 descendants of its own.
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. 2013, 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® MicroCVTM Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is…
Read the full statement (201 words)
The Audit® MicroCVTM Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin.
The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for these analytes. When 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 Audit® MicroCVTM Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCVTM Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130762: Audit Microcv Therapeutic Drug (TDM) 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/K130762
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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