510(k) · Cleared
ClearedQualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee MCC-Ligand Control Levels 1, 2 and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Technologies, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jun 18, 1997 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 18, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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?
Clinical Ilaboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls, provided as a set (Levels 1, 2 and 3) are used as an adjunct to primary control procedure recommended by the manufacturer of immunoassay…
Read the full statement (160 words)
Clinical Ilaboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:
(a) the above mentioned controls, provided as a set (Levels 1, 2 and 3) are used as an adjunct to primary control procedure recommended by the manufacturer of immunoassay systems.
(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;
(c) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.
These controls have been assayed with AXSYM, IMx-and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972080: Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee MCC-Ligand Control Levels 1, 2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972080
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026