510(k) · Cleared
ClearedAudit Microcv Procalcitonin Linearity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · MJX Kit, Serological, Positive Control
Cleared on Jul 22, 2010 as substantially equivalent to K042318 (Aalto Scientific, Ltd., 2004) after a 62-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 22, 2010
- Review
- 62 days
- Class
- Class I
- Product code
- MJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910440 (1991). No later device cites it as a predicate yet.
- 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 deviceK101434 Audit Microcv Procalcitonin LinearityAalto Scientific, Ltd. · 2010
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) | K101434 | Audit Microcv Procalcitonin Linearity | Aalto Scientific, Ltd. | 2010 | — |
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 MJX? 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…MJX E. Device to Which Substantial Equivalence is Claimed AuditTm MiCroCVTm General Chemnistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318 Page I of F. Description of the Devic… | 2004 |
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 19 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- 11 other devices also cite its predicate K042318.
How does its category compare?
All MJX devicesMJX Kit, Serological, Positive Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MJX
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MJX
Too few MJX 510(k)s in any year since 2007 to give a median.
Recalls per year · MJX
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJX
No MAUDE report names MJX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AuditTM MicroCVTM Procalcitonin Linearity Set is assayed quality control material
consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels
demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to
simulate human patient serum samples for the purpose of monitoring the precision and to detect
systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product
may be used as an assayed quality control material for Procalcitonin analyte.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101434: Audit Microcv Procalcitonin Linearity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101434
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