510(k) · Cleared
ClearedFastpack Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualigen, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 8, 2013 as substantially equivalent to K960824 (Medical Analysis Systems, Inc., 1996) and 2 other predicates after a 94-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 8, 2013
- Review
- 94 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942566 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942566 | Imx Ultrasensistive HTSH II | Abbott Laboratories | 1994 | — |
| −1 | K052301 | Fastpack TSH Immunoassay | Qualigen, Inc. | 2006 | 1 |
| 0 (this device) | K123725 | Fastpack Control Kit | Qualigen, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K960824 | Immunology ControlSummary page 2…h 8, 2013 Devices to Which Substantial Equivalence is Claimed Immunology Control (containing FT4, testosterone, and hCG) Medical Analysis Systems, Camarillo, California K960824 FastPack®& Controls (containing PSA) Qualigen, Inc. Carlsbad, California K003095 FastPack®)TSH Controls Qualigen, Inc. Carlsbad… | 1996 |
| * | K003095 | Fastpack ControlSummary page 2…(containing FT4, testosterone, and hCG) Medical Analysis Systems, Camarillo, California K960824 FastPack®& Controls (containing PSA) Qualigen, Inc. Carlsbad, California K003095 FastPack®)TSH Controls Qualigen, Inc. Carlsbad, California K052301 Device Description FastPack® Control Kit is prepared in a… | 2000 |
| * | K052301 | Fastpack TSH ImmunoassaySummary page 2…marillo, California K960824 FastPack®& Controls (containing PSA) Qualigen, Inc. Carlsbad, California K003095 FastPack®)TSH Controls Qualigen, Inc. Carlsbad, California K052301 Device Description FastPack® Control Kit is prepared in a synthetic matrix containing chemicals, preservatives, and stabilizer… | 2006 |
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 19 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K960824.
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. 2013, this device’s year, is highlighted.
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 FastPack® Control Kit is an assayed quality control for the verification of the accuracy and precision of the FastPack® and FastPack® IP Systems when used for the quantitative determination of the analytes listed in the package insert. The following analytes are included in the package insert:
- Free Thyroxine (FT4)
- Human Chorionic Gonadotropin (hCG)
- Testosterone
- Total Prostate Specific Antigen (tPSA)
- Thyroid Stimulating Hormone (TSH)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123725 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123725: Fastpack Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123725
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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