510(k) · Cleared
ClearedValidate Urine Chemistry Calibration Verification Test Sets
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 Mar 25, 2005 as substantially equivalent to K012117 (Maine Standards Co., 2001) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Mar 25, 2005
- Review
- 25 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K870252 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK870252 Document (TM) Multi-Analyte Linearity Test SetCasco Standards · 1987
- 1 generation backK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
- This deviceK050504 Validate Urine Chemistry Calibration Verification Test SetsMaine Standards Co. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870252 | Document (TM) Multi-Analyte Linearity Test Set | Casco Standards | 1987 | — |
| −1 | K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001 | Maine Standards Co. | 2001 | — |
| 0 (this device) | K050504 | Validate Urine Chemistry Calibration Verification Test Sets | Maine Standards Co. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 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? (3)
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 |
|---|---|---|---|
| * | K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001Summary page 1…21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I Predicate Device: 1. Chem I Calibration Verification Test Set (K012117), manufactured by Maine Standards Company, Windham, ME. 2. Bio-Rad Liquichek Urine Chemistry Control (K934357),… | 2001 |
| * | K934357 | Liquichek Routine Urime Chemistry Control, Levels 1 & 2Summary page 1…Chem I Calibration Verification Test Set (K012117), manufactured by Maine Standards Company, Windham, ME. 2. Bio-Rad Liquichek Urine Chemistry Control (K934357), Bio-Rad Laboratories, Irvine, CA 3. College of American Pathologists (CAP) Urine Chemistry Survey (Calibration… | 1993 |
| * | — | College of American Pathologists (CAP) Urine Chemistry Survey (Calibration Verification… Named without a submission number |
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 18 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K012117.
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® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050504: Validate Urine Chemistry Calibration Verification Test Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050504
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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