Theratest Laboratories, Inc.
Lombard, IL, US
THERATEST LABORATORIES, INC. appears in FDA device records in Lombard, IL. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Theratest Laboratories, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Thera-Test Laboratories, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Theratest Laboratories, Inc. between 1991 and 2010. The busiest year on record is 1995, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 2 |
| 2000 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090753 | THERATEST EL-ANTI-CCP/2 | NHX | Substantially Equivalent | |
| K092757 | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR | MSV | Substantially Equivalent | |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | JZO | Substantially Equivalent | |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | MVM | Substantially Equivalent | |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | MOB | Substantially Equivalent | |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | MID | Substantially Equivalent | |
| K051066 | THERATEST EL-ANA PROFILES | LKP | Substantially Equivalent | |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | LJM | Substantially Equivalent | |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | MQA | Substantially Equivalent | |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | LJM | Substantially Equivalent | |
| K002559 | EL-ANA PROFILES-2K1 | LJM | Substantially Equivalent | |
| K982622 | EL-ANA PROFILES: EL-ENA/5 | LLL | Substantially Equivalent | |
| K982150 | EL-ANA PROFILES: EL-ENA/4 | LLL | Substantially Equivalent | |
| K973882 | EL-B2GP1SCR | MSV | Substantially Equivalent | |
| K972790 | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR | MSV | Substantially Equivalent | |
| K962050 | THERATEST EL-RFSCR | DHR | Substantially Equivalent | |
| K955481 | THERATEST KIT (MODIFICATION) | LJM | Substantially Equivalent | |
| K954106 | THERATEST LAB, INC., EL-ANASCR KIT | LJM | Substantially Equivalent | |
| K950716 | THERATEST EL-ANA PROFILES TEST SYSTEM | LJM | Substantially Equivalent | |
| K941398 | EL-RF/3 (IGM-IGG-IGA) KIT | DHR | Substantially Equivalent | |
| K933712 | EL-RF TEST SYSTEM: EL-RF-IGM KIT | DHR | Substantially Equivalent | |
| K914454 | THE THERATEST EL-ANA PROFILES | LKJ | Substantially Equivalent | |
| K905301 | THE THERATEST ACA TEST | GFO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1421346 | 1421346 | THERATEST LABORATORIES, INC. | 1120 N Du Page Ave, Lombard, IL 60148 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFOActivated Partial Thromboplastin
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- MQAAnti-Ribosomal P Antibodies
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- MSTAntibodies, Gliadin
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- LLLExtractable Antinuclear Antibody, Antigen And Control
- MIDSystem, Test, Anticardiolipin Immunological
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2382-2021 | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 | The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128 | Class II | Terminated | |
| Z-2381-2021 | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 | Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129 | Class II | Terminated | |
| Z-1546-2012 | RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA). | The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA test run. | Terminated | ||
| Z-0835-06 | EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148 | The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain