510(k) · Cleared
ClearedAudit Microcv Vitamin D 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 Apr 26, 2013 as substantially equivalent to K101427 (Aalto Scientific, Ltd., 2010) after a 37-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Apr 26, 2013
- Review
- 37 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910440 (1991). No later device cites it as a predicate yet.
- 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 deviceK130764 Audit Microcv Vitamin D Linearity SetAalto Scientific, Ltd. · 2013
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) | K130764 | Audit Microcv Vitamin D Linearity Set | Aalto Scientific, Ltd. | 2013 | — |
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: Audits MictoCVTm hs-CRP Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K101427 E. Description-of the Device The Audit® MicroCVTh Vitamin 0 Linearity Set is an assayed quality control material consisting of fi… | 2010 |
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 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.
- 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® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D. The product is intended for use…
Read the full statement (154 words)
The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.
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 Vitamin D. 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® MicroCV™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130764 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130764: Audit Microcv Vitamin D Linearity Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130764
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