510(k) · Cleared
ClearedStandard a, Standard B, Standard C, Cal, Slope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · JIT Calibrator, Secondary
Cleared on Dec 21, 2001 after a 31-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 21, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JIT? 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? (8)
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 |
|---|---|---|---|
| * | — | AVL BP0936 Standard A Named without a submission number | |
| * | — | AVL BP0937 Standard B Named without a submission number | |
| * | — | AVL BP0938 Standard C Named without a submission number | |
| * | — | AVL BP0442 Standard B Named without a submission number | |
| * | — | AVL BP1232 Standard A Named without a submission number | |
| * | — | AVL BP1218 Standard B Named without a submission number | |
| * | — | AVL BP1203 Standard A Named without a submission number | |
| * | — | AVL BP1201 Standard B 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.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent AVL 98X series Analyzers. AVL Scientific Corp is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents. Standard A AV-BP0936D | 982, 983, 985, 988-3 (Cl, Li) Standard B AV-BP0937D | 985, 988-3 (Cl, Li) Standard B AV-BP0442D | 982, 983…
Read the full statement (136 words)
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent AVL 98X series Analyzers. AVL Scientific Corp is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents.
Standard A AV-BP0936D | 982, 983, 985, 988-3 (Cl, Li)
Standard B AV-BP0937D | 985, 988-3 (Cl, Li)
Standard B AV-BP0442D | 982, 983
Standard C AV-BP0938D | 985, 988-3 (Li)
Standard A AV-BP1232D | 984, 987, 988-3 (Ca), 988-4
Standard B AV-BP1218D | 984, 987, 988-3 (Ca), 988-4
Standard A AV-BP1203D | 986
Standard B AV-BP1201D | 986
Mission reagents are intended to serve as direct replacements to like named products manufactured by AVL.
The products encompassed are to be handled using normal laboratory precautions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013850 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013850: Standard a, Standard B, Standard C, Cal, Slope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013850
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026