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510(k) Data Aggregation
(88 days)
The GenaCheck COVID-19 Rapid Self-Test is a visually read lateral flow immunoassay test intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from March 2024 to October 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspect.
The GenaCheck® COVID-19 Rapid Self-Test is a rapid, qualitative latex particles based immunochromatography test. The test is designed to detect nucleocapsid protein antigen in anterior nasal swab specimens from individuals who show symptoms of COVID-19 infection within the first five (5) days of symptom onset. The GenaCheck® COVID-19 Rapid Self-Test is validated for use from direct specimens testing without transport media.
The test package is composed of the following components:
- Test Cassette within a Foil Pouch
- Lysis Buffer
- Anterior Nasal Swab
- Quick Reference Instructions
The test cassette contains a test strip (binding pad) in a plastic housing. The binding pad is a nitrocellulose membrane with two regions: test region (T) and control region (C).
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(183 days)
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powderfree, ambidextrous with beaded cuff, purple colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.
Here's a breakdown of the acceptance criteria and study information for the GenaCheck™ Nitrile Powder Free Examination Glove, based on the provided FDA document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Property | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Performance (ASTM D6319-19) | |||
| Length | Physical Dimensions Test | XS/S: ≥220 mm; M/L/XL: ≥230 mm | XS/S: ≥220 mm (Pass); M/L/XL: ≥230 mm (Pass) |
| Width | Physical Dimensions Test | XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm | XS: 73-78 mm (Pass); S: 84-88 mm (Pass); M: 93-98 mm (Pass); L: 103-108 mm (Pass); XL: 113-118 mm (Pass) |
| Thickness | Physical Dimensions Test | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Finger: 0.069-0.109 mm (Pass); Palm: 0.052-0.079 mm (Pass) |
| Watertightness (ASTM D5151-19) | |||
| Freedom from Holes | Watertightness Test | Met the requirements of ASTM D5151 AQL 2.5 | 0/125 (Pass) |
| Powder Content (ASTM D6124-06) | |||
| Powder Content | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.27-0.41 mg (Pass) |
| Physical Properties (ASTM D412-16) | |||
| Before Aging - Tensile Strength | Physical properties | ≥14 MPa | 14-27 MPa (Pass) |
| Before Aging - Ultimate Elongation | Physical properties | ≥500% | 516-769 % (Pass) |
| After Aging - Tensile Strength | Physical properties | ≥14 MPa | 14-20 MPa (Pass) |
| After Aging - Ultimate Elongation | Physical properties | ≥400% | 452-662 % (Pass) |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | Cytotoxicity | Under conditions of the study, device extract is cytotoxic. (This criteria seems to indicate the expected outcome of the test, rather than a desired performance threshold; however, the intent is likely to confirm that it is not cytotoxic, as shown in the predicate comparison for the predicate device, which states "device extract is cytotoxic" and is marked as "Same." This implies the predicate itself also had this result, and it's being compared for similarity, not necessarily for a "pass/fail" against a non-cytotoxic ideal in this context for substantial equivalence.) | Under conditions of the study, device extract is cytotoxic (Result confirms similarity to predicate's reported extract cytotoxicity). Note: Given the context of a 510(k) for an examination glove, this result, while listed as "cytotoxic", aligns with the predicate and might be interpreted as acceptable within the framework of demonstrating substantial equivalence, meaning the new device is no worse than the predicate in terms of cytotoxicity. It's unusual for "cytotoxic" to be an acceptance criteria, more commonly "non-cytotoxic". This phrasing might indicate a specific interpretation or comparison to the predicate's known characteristics. More commonly, "non-cytotoxic" is the desired outcome. |
| Acute Systemic Toxicity (ISO 10993-11) | Acute Systemic Toxicity | Under conditions of the study, device extract did not show acute systemic toxicity in vivo | Under conditions of the study, device extract did not show acute systemic toxicity in vivo (Pass) |
| Irritation (ISO 10993-23) | Irritation | Under conditions of the study, the device was non-irritating | Under conditions of the study, the device was non-irritating (Pass) |
| Sensitization (ISO 10993-10) | Sensitization | Under conditions of the study, the device is non-sensitizing | Under conditions of the study, the device is non-sensitizing (Pass) |
| Chemopermeation (ASTM D6978-05) | |||
| Carmustine (3.3 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication highlights "low permeation time" | 22.8 Minutes |
| Cisplatin (1.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication is for comparison to similar predicate results | > 240 Minutes |
| Cyclophosphamide (20.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Dacarbazine (10.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Doxorubicin HCI (2.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Etoposide (20.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Fluorouracil (50.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Methotrexate (25.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Mitomycin C (0.5 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Paclitaxel (6.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Thiotepa (10.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication highlights "low permeation time" | 37.9 Minutes |
| Vincristine Sulfate (1.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Fentanyl Citrate Inj. (100mcg/2ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
Study Details:
For medical gloves, the "study" demonstrating that the device meets acceptance criteria typically refers to a series of non-clinical, laboratory bench tests conducted according to recognized consensus standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. However, it references the standards used, which often specify sample sizes.
- For Watertightness Test (ASTM D5151-19), the result "0/125/Pass" indicates that 125 samples were tested, with 0 failures.
- For other tests like physical dimensions, powder content, and physical properties, the sample sizes are described by the respective ASTM standards but not explicitly listed in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical testing" (bench tests) rather than human subject studies, so there's no "retrospective or prospective" status in the same sense as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable for this type of device and study. The "ground truth" for non-clinical performance and material properties standards is established by the specifications defined within the referenced ASTM and ISO standards themselves (e.g., a tensile strength of ≥14 MPa, or a specific AQL for holes). There are no human experts classifying outcomes in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" are used for human-reviewed data sets (e.g., medical image interpretation consensus). For bench testing against pre-defined engineering and material specifications, the results are quantitative measurements compared directly to the acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of diagnostic tools (e.g., AI algorithms for interpreting medical images) with and without human readers' involvement. The device here is a medical glove, for which MRMC studies are not applicable.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study in the context of an "algorithm only" performance was not done. This concept is specific to software medical devices or AI algorithms. The GenaCheck™ glove is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on established industry and regulatory standards.
- For physical properties, it's defined quantities like minimum tensile strength (e.g., ≥14 MPa).
- For resistance to permeation by chemotherapy drugs, it's the measured "breakthrough detection time" according to the specified method (ASTM D6978-05).
- For biocompatibility, it's the absence of adverse biological reactions (non-irritating, non-sensitizing, no acute systemic toxicity, and comparison to predicate regarding cytotoxicity) as defined by ISO 10993 series.
8. The Sample Size for the Training Set
There is no training set for this device. Training sets are applicable to machine learning algorithms. The GenaCheck™ glove is a physical product, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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