Helena Laboratories, Corp.
Beaumont, TX, US
HELENA LABORATORIES, CORP. appears in FDA device records in Beaumont, TX. FDA records list 282 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 282FDA records hold 282 510(k) clearances for Helena Laboratories, Corp. between 1978 and 2022. The busiest year on record is 1987, with 22. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 19 |
| 1980 | 19 |
| 1981 | 12 |
| 1982 | 16 |
| 1983 | 19 |
| 1984 | 13 |
| 1985 | 3 |
| 1986 | 6 |
| 1987 | 22 |
| 1988 | 12 |
| 1989 | 15 |
| 1990 | 16 |
| 1991 | 19 |
| 1992 | 19 |
| 1993 | 10 |
| 1994 | 10 |
| 1995 | 8 |
| 1996 | 8 |
| 1997 | 3 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 7 |
| 2003 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213396 | SPIFE A1AT kit | OBZ | Substantially Equivalent | |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | GKA | Substantially Equivalent | |
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | JJY | Substantially Equivalent | |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | GGC | Substantially Equivalent | |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | GHR | Substantially Equivalent | |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | CFF | Substantially Equivalent | |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | JPA | Substantially Equivalent | |
| K050053 | HEMORAM/AGGRAM ANALYZER | JPA | Substantially Equivalent | |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | CFF | Substantially Equivalent | |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | JOZ | Substantially Equivalent | |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | JHY | Substantially Equivalent | |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | CFE | Substantially Equivalent | |
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | JHO | Substantially Equivalent | |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | JBP | Substantially Equivalent | |
| K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | CIN | Substantially Equivalent | |
| K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | CFE | Substantially Equivalent | |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | JBP | Substantially Equivalent | |
| K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | JHO | Substantially Equivalent | |
| K012723 | PLATELETWORKS | JOZ | Substantially Equivalent | |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | DEW | Substantially Equivalent | |
| K003359 | COLOSCREEN-ES | KHE | Substantially Equivalent | |
| K000603 | SPIFE CHOLESTEROL PROFILE KIT | JHO | Substantially Equivalent | |
| K992971 | REP CHOLESTEROL PROFILE KIT | JHO | Substantially Equivalent | |
| K992199 | ACID HEMOGLOBIN KIT | JBD | Substantially Equivalent | |
| K990998 | POLYSLIT IFE KIT | CFF | Substantially Equivalent | |
| K982426 | SPIFE ALKALINE HEMOGLOBIN | JBD | Substantially Equivalent | |
| K982639 | SPIFE URINE IFE | DAO | Substantially Equivalent | |
| K980671 | COLOSCREEN-ES | KHE | Substantially Equivalent | |
| K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL | JHO | Substantially Equivalent | |
| K974609 | REP CHOLESTEROL PROFILE CONTROL-II | JJX | Substantially Equivalent | |
| K973040 | SPIFE IFE-6 | CFF | Substantially Equivalent | |
| K972274 | SPIFE | CEF | Substantially Equivalent | |
| K973316 | REP SPE VIS-60/40 KIT | CEF | Substantially Equivalent | |
| K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 | JHO | Substantially Equivalent | |
| K964471 | REP FLUR CHOLESTEROL-60 KIT | JHO | Substantially Equivalent | |
| K964453 | REP 3 FLUR SPE-60 KIT | CEF | Substantially Equivalent | |
| K961908 | THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 | JPA | Substantially Equivalent | |
| K960571 | RAPID ELECTROPHORESIS ANALYZER | JHO | Substantially Equivalent | |
| K952321 | PORCINE FACTOR VIII;C REAGENT | GGN | Substantially Equivalent | |
| K952667 | CHROM Z-HEPARIN, CAT. NO 5242 | KFF | Substantially Equivalent | |
| K952668 | CHROM Z-F:VIII, CAT. NO. 5241 | GGP | Substantially Equivalent | |
| K952666 | CHROM Z-PROTEIN C, CAT. NO. 5243 | GGP | Substantially Equivalent | |
| K952669 | CHROM Z-PLASMINOGEN, CAT. NO. 5244 | GGP | Substantially Equivalent | |
| K951943 | CHROM Z CHROMOGENIC ASSAYS | JBQ | Substantially Equivalent | |
| K951820 | THROMBOPLASTIN-LI REAGENT | GJS | Substantially Equivalent | |
| K952252 | ADP REAGENT, MODIFIED | GHR | Substantially Equivalent | |
| K951497 | CASCASE 480 SNSLYZER | JPA | Substantially Equivalent | |
| K946274 | COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN | LCP | Substantially Equivalent | |
| K950801 | CARDIO REP LD CONTROL - CAT NO. 3325 | JJT | Substantially Equivalent | |
| K950590 | REP CHOLESTEROL PROFILE CONTROL | JJX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1618982 | 1618982 | HELENA LABORATORIES, CORP. | 1530 Lindbergh Dr, BEAUMONT, TX 77707 US | 2026 | and 37 more, listed in full below |
| 1644474 | 1000116989 | HELENA LABORATORIES, CORP. | 3795 WASHINGTON BLVD., BEAUMONT, TX 77705 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- GFOActivated Partial Thromboplastin
- JBPActivated Whole Blood Clotting Time
- JBYAggregometer, Platelet, Photo-Optical Scanning
- JBXAggregrometer, Platelet
- IDAAlcian Blue
- JBQAntithrombin Iii Quantitation
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JHTChromatographic Separation, Cpk Isoenzymes
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio
- JHYColorimetric Method, Cpk Or Isoenzymes
- JCMControl, Hemoglobin, Abnormal
- GGCControl, Plasma, Abnormal
- JCADevice, Bleeding Time
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- JHOElectrophoretic Separation, Lipoproteins
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- CEFElectrophoretic, Protein Fractionation
- JHXFluorometric Method, Cpk Or Isoenzymes
- DAHGamma Globulin, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- CZNIga, Fitc, Antigen, Antiserum, Control
- CZJIgd, Antigen, Antiserum, Control
- DAQIgg (Fd Fragment Specific), Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- GKPInstrument, Coagulation, Automated
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- GJWPipette, Pasteur
- GJGPipette, Quantitative, Hematology
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- DDXPlasminogen, Antigen, Antiserum, Control
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- CFPRadioimmunoassay, Immunoreactive Insulin
- GHRReagent, Platelet Aggregation
- HZOStain, Ponceau
- JBDSystem, Analysis, Electrophoretic Hemoglobin
- GKRSystem, Hemoglobin, Automated
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- IABToluidine Blue
- GIOTube, Collection, Capillary Blood
- JHWU.V. Method, Cpk Isoenzymes
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1975-2023 | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result. | Class II | Open, Classified | |
| Z-1244-2022 | V8 Immunodisplacement Kit REF 1803 | Due to microbial growth causing interference with interpretation. | Class II | Open, Classified | |
| Z-1108-2021 | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only. | Intermittent potential for shorter than expected clot times. | Class II | Terminated | |
| Z-0635-2021 | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. | Due to complaints received associated with cracked/split test tube caps. | Class II | Open, Classified | |
| Z-1950-2019 | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. | Class II | Open, Classified | |
| Z-1949-2019 | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. | Class II | Open, Classified | |
| Z-0537-2020 | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use, | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth. | Class III | Open, Classified | |
| Z-0536-2020 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3) | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth. | Class III | Open, Classified | |
| Z-0297-2020 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users. | Class III | Open, Classified | |
| Z-2761-2019 | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX. | Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. | Class II | Terminated | |
| Z-0045-2020 | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | The plates do not have wells punched for the controls in the patient 1 area. | Class II | Terminated | |
| Z-0106-2019 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling of Substrate (brown bottle and cap): "Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid): "Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate. | Class II | Terminated | |
| Z-0561-2019 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY | Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected. | Class II | Terminated | |
| Z-0529-2019 | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis. | Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted. | Class III | Terminated | |
| Z-2434-2019 | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. | Class II | Terminated | |
| Z-0594-2019 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood. | Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain