Qualigen Inc
Carlsbad, CA, US
QUALIGEN, INC. appears in FDA device records in Carlsbad, CA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Qualigen Inc between 2000 and 2019. The busiest year on record is 2000, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2002 | 2 |
| 2003 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2015 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | CDZ | Substantially Equivalent | |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit | DCK | Substantially Equivalent | |
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | MRG | Substantially Equivalent | |
| K123725 | FASTPACK CONTROL KIT | JJY | Substantially Equivalent | |
| K101388 | FASTPACK TESTO IMMUNOASSAY | CDZ | Substantially Equivalent | |
| K101390 | FASTPACK TSH IMMUNOASSAY | JLW | Substantially Equivalent | |
| K072264 | FASTPACK HCG IMMUNOASSAY | JHI | Substantially Equivalent | |
| K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | JJX | Substantially Equivalent | |
| K052301 | FASTPACK TSH IMMUNOASSAY | JLW | Substantially Equivalent | |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | CEC | Substantially Equivalent | |
| K022533 | FASTPACK TESTOSTERONE CALIBRATOR | JIT | Substantially Equivalent | |
| K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY | CDZ | Substantially Equivalent | |
| K003096 | FASTPACK CALIBRATORS | JIT | Substantially Equivalent | |
| K003095 | FASTPACK CONTROL | JJX | Substantially Equivalent | |
| K003094 | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | LTJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032087 | 3003355251 | QUALIGEN, INC. | 2042 CORTE DEL NOGAL, CARLSBAD, CA 92011 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- CECRadioimmunoassay, Free Thyroxine
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- MRGSystem, Test, Vitamin D
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0805-2025 | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks. | Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age. | Class III | Open, Classified | |
| Z-0022-2025 | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer | Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected. | Class II | Open, Classified | |
| Z-1672-2020 | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P | The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma. | Class II | Terminated | |
| Z-3112-2017 | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit | Specific lots have been reported to produce falsely lower than expected results for Vitamin D | Class II | Terminated | |
| Z-0550-2014 | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. | Class II | Terminated | |
| Z-0549-2014 | FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System. | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. | Class II | Terminated | |
| Z-0548-2014 | FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System. | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. | Class II | Terminated | |
| Z-0547-2014 | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System. | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. | Class II | Terminated | |
| Z-0500-2009 | FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System. | The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations. | Terminated | ||
| Z-0090-04 | Device to determine quantitative total testosterone in human serum | Kits may produce results that are falsely elevated. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain