510(k) · Cleared
Recalled · Class II · 2013Fastpack Free T4 Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualigen, Inc. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Jul 3, 2003 as substantially equivalent to K902834 (Abbott Laboratories, 1990) after a 153-day review. Its family tree reaches back 1 generation to 1990. It has been recalled once.
- Decided
- Jul 3, 2003
- Review
- 153 days
- Class
- Class II
- Product code
- CEC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902834 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902834 Abbott Imx Free T4Abbott Laboratories · 1990 · Recalled
- This deviceK030329 Fastpack Free T4 ImmunoassayQualigen, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902834 | Abbott Imx Free T4 | Abbott Laboratories | 1990 | 1 |
| 0 (this device) | K030329 | Fastpack Free T4 Immunoassay | Qualigen, Inc. | 2003 | — |
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 CEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEC device
- #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K902834 | Abbott Imx Free T4Summary page 1…ame: Quantitative Determination of Free T4 in Human Serum 3. Predicate Abbott Laboratories I M x Free T4 (K902834) device 4. Device Fastpack@Free T4 Immunoassay Reagents description The Fastpack@F… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2013 | Class II | Z-0549-2014 | Process change control | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEC
238in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEC
213in 2025
MAUDE reports naming product code CEC, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 3 | 7 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 3 | 238 | 0 | 40 |
| 2015 | 1 | — | 0 | 166 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 1 | — | 0 | 196 |
| 2018 | 2 | — | 1 | 199 |
| 2019 | 0 | — | 0 | 167 |
| 2020 | 0 | — | 0 | 106 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 1 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 276 |
| 2025 | 0 | — | 0 | 213 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FastPack" Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The Fastpack@Free Td Immunoassay is designed for use with the Fastpack@Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of yroid dysfunction.
The FastPack@ TestoEree Tq Calibrator is intended to calibrate the FastF'ack@Analyzer system when used for the quantitative determination of Total Testosterone or Free T4 in hwnan serum
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030329: Fastpack Free T4 Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030329
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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