510(k) · Cleared
ClearedAudit Microcv Immunoassay 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 Oct 16, 2006 as substantially equivalent to K042318 (Aalto Scientific, Ltd., 2004) after a 38-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 16, 2006
- Review
- 38 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910440 (1991). 2 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 deviceK062668 Audit Microcv Immunoassay Linearity SetAalto Scientific, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK112143 Audit Microcv T-Uptake LinearityAalto Scientific, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK103601 Audit Microcv Immunoassay Linearity SetAalto Scientific, Ltd. · 2011
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 |
|---|---|---|---|---|---|
| −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) | K062668 | Audit Microcv Immunoassay Linearity Set | Aalto Scientific, Ltd. | 2006 | — |
| +1 | K112143 | Audit Microcv T-Uptake Linearity | Aalto Scientific, Ltd. | 2012 | — |
| +1 | K103601 | Audit Microcv Immunoassay Linearity Set | Aalto Scientific, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K042318 | Audit Microcv General Chemistry Linearity SetSummary page 1…JJY E. Device to Which SubstantialEquivalence is Claimed AuditTM MicroCVTM General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318 Page 2.1 of 2.2… | 2004 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112143 (Aalto Scientific, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K042318.
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.
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 AuditTM MicroCVTM Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product…
Read the full statement (153 words)
The AuditTM MicroCVTM Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
In addition, Level A - E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062668: Audit Microcv Immunoassay 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/K062668
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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