510(k) · Cleared
ClearedCalibration Verification Assessment (Cva)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Apr 3, 1996 as substantially equivalent to K942822 (R&D Systems, Inc., 1994) after a 54-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 3, 1996
- Review
- 54 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942822 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK942822 CBC-Line Hematology Linearity ControlR&D Systems, Inc. · 1994
- This deviceK960557 Calibration Verification Assessment (Cva)Streck Laboratories, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942822 | CBC-Line Hematology Linearity Control | R&D Systems, Inc. | 1994 | — |
| 0 (this device) | K960557 | Calibration Verification Assessment (Cva) | Streck Laboratories, Inc. | 1996 | — |
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 JPK? 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 |
|---|---|---|---|
| * | K942822 | CBC-Line Hematology Linearity ControlSummary page 1…ion Verification Assessment (CVA) Common Name: Assayed hematology control Classification Name: Hematology quality control mixture (§864.8625) Predicate Device: CBC-LINE (K942822) R&D Systems, Inc. Description: CVA is a suspension of stabilized human red blood cells, human white cells, and simulated platel… | 1994 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K942822.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
MAUDE reports naming product code JPK, 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 | 44 | 1 | 14 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 5 | 187 | 0 | 0 |
| 2010 | 4 | 267 | 2 | 5 |
| 2011 | 1 | — | 3 | 56 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 296 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/lhemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.
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/K960557 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960557: Calibration Verification Assessment (Cva).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960557
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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