510(k) · Cleared
ClearedAudit Microcv Beta-Hydroxybutyric Acid Linearity Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Mar 19, 2013 as substantially equivalent to K101427 (Aalto Scientific, Ltd., 2010) after a 55-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Mar 19, 2013
- Review
- 55 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910440 (1991). 3 later devices descend from it, 3 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 backK101427 Audit Microcv HS-CRP Linearity SetAalto Scientific, Ltd. · 2010
- This deviceK130157 Audit Microcv Beta-Hydroxybutyric Acid Linearity SetAalto Scientific, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK143571 Audit MicroControls Linearity LQ Cystatin-CAalto Scientific, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK143026 Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityAalto Scientific, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK142978 Audit MicroControls Linearity LQ Special DiabetesAalto Scientific, Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K143571Audit MicroControls Linearity LQ Cystatin-CAalto Scientific, Ltd. · 2015 · cites it directly0descendants
- K143026Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityAalto Scientific, Ltd. · 2014 · cites it directly0descendants
- K142978Audit MicroControls Linearity LQ Special DiabetesAalto Scientific, Ltd. · 2014 · cites it directly0descendants
View 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 | K101427 | Audit Microcv HS-CRP Linearity Set | Aalto Scientific, Ltd. | 2010 | — |
| 0 (this device) | K130157 | Audit Microcv Beta-Hydroxybutyric Acid Linearity Set | Aalto Scientific, Ltd. | 2013 | — |
| +1 | K143571 | Audit MicroControls Linearity LQ Cystatin-C | Aalto Scientific, Ltd. | 2015 | — |
| +1 | K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | Aalto Scientific, Ltd. | 2014 | — |
| +1 | K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 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 JJX? 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 |
|---|---|---|---|
| * | K101427 | Audit Microcv HS-CRP Linearity SetSummary page 1…ivalence is Claimed Product Trade Name: Audit® MicroCVTM hs-CRP Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K101427 E. Description of the Device The Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material c… | 2010 |
What descends from it? (3)
3 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 6.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K143571 (Aalto Scientific, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K101427.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for…
Read the full statement (152 words)
The Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutyric Acid.
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 Beta-Hydroxybutyric Acid. 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 Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-1-ydroxybutyric Acid assay. The Audit@ MicroCVTM Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130157: Audit Microcv Beta-Hydroxybutyric Acid 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/K130157
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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