510(k) · Cleared
ClearedAudit Microcv HS-CRP 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 Dec 23, 2010 as substantially equivalent to K042318 (Aalto Scientific, Ltd., 2004) after a 216-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it.
- Decided
- Dec 23, 2010
- Review
- 216 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910440 (1991). 5 later devices descend from it, 2 citing it directly.
- 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 deviceK101427 Audit Microcv HS-CRP Linearity SetAalto Scientific, Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK130157 Audit Microcv Beta-Hydroxybutyric Acid Linearity SetAalto Scientific, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK143571 Audit MicroControls Linearity LQ Cystatin-CAalto Scientific, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK143026 Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityAalto Scientific, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK142978 Audit MicroControls Linearity LQ Special DiabetesAalto Scientific, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK130764 Audit Microcv Vitamin D Linearity SetAalto Scientific, Ltd. · 2013
Most influential descendants
Showing 5 of 5 · See all- K130157Audit Microcv Beta-Hydroxybutyric Acid Linearity SetAalto Scientific, Ltd. · 2013 · cites it directly3descendants
- K143571Audit MicroControls Linearity LQ Cystatin-CAalto Scientific, Ltd. · 2015 · 2 generations on0descendants
- K143026Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityAalto Scientific, Ltd. · 2014 · 2 generations on0descendants
- K142978Audit MicroControls Linearity LQ Special DiabetesAalto Scientific, Ltd. · 2014 · 2 generations on0descendants
- K130764Audit Microcv Vitamin D Linearity SetAalto Scientific, Ltd. · 2013 · cites it directly0descendants
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) | K101427 | Audit Microcv HS-CRP Linearity Set | Aalto Scientific, Ltd. | 2010 | — |
| +1 | K130157 | Audit Microcv Beta-Hydroxybutyric Acid Linearity Set | Aalto Scientific, Ltd. | 2013 | — |
| +2 | K143571 | Audit MicroControls Linearity LQ Cystatin-C | Aalto Scientific, Ltd. | 2015 | — |
| +2 | K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | Aalto Scientific, Ltd. | 2014 | — |
| +2 | K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | 2014 | — |
| +1 | K130764 | Audit Microcv Vitamin D Linearity Set | Aalto Scientific, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K042318 | Audit Microcv General Chemistry Linearity SetSummary page 1…JJX E. Device to Which Substantial Equivalence is Claimed AuditTM MicroCVTM General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318 Page 3 of 3I F. Description of th… | 2004 |
What descends from it? (5)
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 19 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130157 (Aalto Scientific, Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K042318.
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. 2010, 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 AuditTM NieroCVTM- hs-CRP Linearity Set is assayed quality control material consisting of live levels human based serum. Each level contains High Sensitivity C-Reactive Protein ([is - CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hts -CRP) anaiyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of…
Read the full statement (150 words)
The AuditTM NieroCVTM- hs-CRP Linearity Set is assayed quality control material consisting of live levels human based serum. Each level contains High Sensitivity C-Reactive Protein ([is - CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hts -CRP) anaiyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRPI). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. 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 product is intended Mbr use with quantitative assays on the indicated analyzer provided in the labeling. The AuditTM MicroCVTrm hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101427: Audit Microcv HS-CRP 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/K101427
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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