510(k) · Cleared
ClearedQualitrol Immunology Control, Level 1, 2 and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seracare Technology · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Nov 12, 1999 as substantially equivalent to K945651 (Bio-Rad, 1995) after an 87-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 12, 1999
- Review
- 87 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945651 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945651 Liquichek (TM Immunology Control, Levels 1.2. and 3Bio-Rad · 1995
- This deviceK992770 Qualitrol Immunology Control, Level 1, 2 and 3Seracare Technology · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945651 | Liquichek (TM Immunology Control, Levels 1.2. and 3 | Bio-Rad | 1995 | — |
| 0 (this device) | K992770 | Qualitrol Immunology Control, Level 1, 2 and 3 | Seracare Technology | 1999 | — |
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 |
|---|---|---|---|
| * | K945651 | Liquichek (TM Immunology Control, Levels 1.2. and 3Summary page 1…, Product code: JJY 21 CFR 862:1660 : Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Predicate device: LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651 Device description: Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immuno… | 1995 |
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 K945651.
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?
Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.
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/K992770 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992770: Qualitrol Immunology Control, Level 1, 2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992770
Report an extraction error
Are you the manufacturer?
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