510(k) · Cleared
ClearedValidate Chem 10 Calibration Verification Test Set, Model 110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Co. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 6, 2003 as substantially equivalent to K910440 (Casco Standards, 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 40 later devices descend from it.
- Decided
- Jan 6, 2003
- Review
- 88 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910440 (1991). 40 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910440 Document Reflectance II Linearity Test SetCasco Standards · 1991
- This deviceK023410 Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003
- Descendant · cites it directly · 39 of its ownK042318 Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004
- Descendant · 2 generations on · 14 of its ownK100715 Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010
- Descendant · 3 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 4 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK101427 Audit Microcv HS-CRP Linearity SetAalto Scientific, Ltd. · 2010
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K042318Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004 · cites it directly39descendants
- K100715Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010 · 2 generations on14descendants
- K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 3 generations on13descendants
- K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 4 generations on7descendants
- K101427Audit Microcv HS-CRP Linearity SetAalto Scientific, Ltd. · 2010 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910440 | Document Reflectance II Linearity Test Set | Casco Standards | 1991 | — |
| 0 (this device) | 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 | — |
| +2 | K100715 | Audit Microcv Homocysteine Linearity Set, Model 704M-5 | Aalto Scientific, Ltd. | 2010 | — |
| +3 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +4 | K140258 | Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K101427 | Audit Microcv HS-CRP Linearity Set | Aalto Scientific, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K910440 | Document Reflectance II Linearity Test SetSummary page 1…libration Verification Classification Name: Calibrator, Multi-Analyte Predicate Device: 1. DOCUMENT Reflectance II Test Set, K910440, manufactured by CASCO NERL Diagnostics. 2. Ortho-Clinical Diagnostics VITROS Calibrator Kit… | 1991 |
| * | — | Ortho-Clinical Diagnostics VITROS Calibrator Kit 4 Named without a submission number |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042318 | Audit Microcv General Chemistry Linearity Set | 2004 | 39 |
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?
- Its one ancestor has no recall.
- Of its descendants, K042318 (Aalto Scientific, Ltd., 2004) has gone furthest, with 39 descendants of its own.
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 VALIDATE Chem 10 Calibration Verification Test Set is used by trained laboratory professionals for the determination of linearity, calibration verificatior I and verification of reportable range in automated, semi-automated and manual clinical chemistry systems for the following analytes: alanine aminotransferase, aspartate aminotransferase, gamma-glutarnyl transferase, creatine kinase, lactate dehydrogenase, alkaline phophatase, arnylase, lipase, and total bilirubin The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023410: Validate Chem 10 Calibration Verification Test Set, Model 110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023410
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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