(315 days)
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No
The device description details a standard ELISA assay and data analysis based on a reference curve and normalization, with no mention of AI or ML techniques.
No
The device is an in-vitro diagnostic test kit used to detect levels of a biomarker in urine, which aids in determining the effect of aspirin. It does not provide any therapeutic intervention or treatment.
Yes
This device is designed to determine the levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect. This falls under the definition of a diagnostic device as it provides information used to identify or monitor the presence or absence of a condition (aspirin effect).
No
The device description clearly outlines a physical test kit involving microwell plates, antibodies, reagents, and incubation steps, which are all hardware components. While there is data analysis involved, the core of the device is a laboratory-based immunoassay.
Yes, based on the provided information, the AspirinWorks® Test Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion." This involves testing a sample taken from the human body (in vitro) to provide information about a physiological state (aspirin effect).
- Sample Type: The test is performed on "human urine," which is a biological sample taken from the body.
- Method: It uses an "enzyme-linked immunoassay (ELISA)," which is a common laboratory technique for analyzing biological samples.
- Setting: It is intended for use in "clinical (hospital and reference) laboratories," which are typical settings for IVD testing.
- Professional Use: It is for "professional use only," indicating it requires trained personnel to perform the test, which is characteristic of many IVDs.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories.
Product codes
1020KW, OBW
Device Description
An ELISA for the detection of urinary 11-Dehydro Thromboxane B2 (11dhTxB2). Goat anti-mouse IgG polyclonal antibody (Jackson ImmunoResearch Laboratories, Inc, West Grove, PA) is coated onto 96-microwell plates. Reference, control, and patient samples are diluted in a Tris-based sample diluent (pH 9.0) and added to the microwells. An 11dhTxB2 tracer (11dhTxB2 linked to alkaline phosphatase, (AP); Cayman Chemical Company, Ann Arbor, MI) is then added to all wells except assay blanks, followed by the addition of an anti-11dhTxB2 murine monoclonal antibody (Cayman Chemical Company) to all wells except assay blanks. The maximum binding wells (Bo) contain sample diluent, tracer, and monoclonal antibody, but no unlabeled 11dhTxB2. The plate is then covered with the plastic sheet provided in the kit, and incubated at room temperature on a rotary shaker at 300-600 pm for two hours. The AP-Tracer and unlabeled 11dhTxB2 from the reference curve/controls/samples compete for binding to the anti-11dhTxB2 monoclonal antibody, which is bound to the plate by the goat anti-mouse polyclonal antibody. After incubation, the reaction solution is removed from the wells followed by five washes with TBS/Tween 20. The pNPP substrate is then added and the plate is covered and incubated with shaking for 30 minutes. The reaction is stopped by the addition of Stop Solution (0.1M EDTA) to the wells, and the plate is read at 405-420 mm. Results are compared to the reference curve and expressed in pg/ml. Patient results are then normalized using the creatinine concentration of the sample, as measured by a separate assay.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
For professional use only.
The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Two different clinical studies were employed for the evaluation of the AspirinWorks Test Kit. Results from these studies established a cutoff for aspirin effect at ≤1500 pg 11dhTxB2/mg creatinine. Further analysis revealed that 180/204 (88.2%) of samples from individuals not taking aspirin were above the cutoff value. Analysis of samples from individuals taking various doses of aspirin revealed that 7/163 (4.3%) of 81 mg/day aspirin users indicated a lack of aspirin effect (>1500 pg 11dhTxBy/mg creatinine) and 4/38 (10.5%) of the 325 mg/day aspirin users indicated a lack of aspirin effect. In total, 11/201 (5.5%) of all aspirin users tested indicated a lack of aspirin effect. These percentages are consistent with those in published literature for aspirin non-responsiveness or lack of aspirin effect.
Non-clinical studies show a detection range for the AspirinWorks Test Kit of 300 - 4000 pg/mL, while intra- and inter-assay precision %CV's are all
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the word "corgenix" in a simple, sans-serif font. The "o" in "corgenix" is replaced by a solid black circle. There is a small dot above the "i" in "corgenix".
MAY 2 9 2007
510(K) Summary [As required by 21 CFR 807.92(c)]
Kimberly Hassler
Submitter's Name and Address: Corgenix, Inc. 11575 Main Street Broomfield, CO 80020
Director of Quality and Regulatory Affairs Phone: 303.457.4345 x130 303.457.4519 Fax: Email: khassler@corgenix.com
Contact Name/Information:
Date Summary Prepared: Device Proprietary Name: Regulation Name: Proposed Classification: Proposed Product Code: Predicate Device:
July 17, 2006, Revised on April 3, 2007 AspirinWorks® Test Kit (11-Dehydro Thromboxane B2) Automated platelet aggregation system 21 CFR 864,5700 1020KW VerifyNow™ Aspirin Assay (K042423)
Device Description:
An ELISA for the detection of urinary 11-Dehydro Thromboxane B2 (11dhTxB2). Goat anti-mouse IgG polyclonal antibody (Jackson ImmunoResearch Laboratories, Inc, West Grove, PA) is coated onto 96microwell plates. Reference, control, and patient samples are diluted in a Tris-based sample diluent (pH 9.0) and added to the microwells. An 11dhTxB2 tracer (11dhTxB2 linked to alkaline phosphatase, (AP); Cayman Chemical Company, Ann Arbor, MI) is then added to all wells except assay blanks, followed by the addition of an anti-11dhTxB2 murine monoclonal antibody (Cayman Chemical Company) to all wells except assay blanks. The maximum binding wells (Bo) contain sample diluent, tracer, and monoclonal antibody, but no unlabeled 11dhTxB2. The plate is then covered with the plastic sheet provided in the kit, and incubated at room temperature on a rotary shaker at 300-600 pm for two hours. The AP-Tracer and unlabeled 11dhTxB2 from the reference curve/controls/samples compete for binding to the anti-11dhTxB2 monoclonal antibody, which is bound to the plate by the goat anti-mouse polyclonal antibody. After incubation, the reaction solution is removed from the wells followed by five washes with TBS/Tween 20. The pNPP substrate is then added and the plate is covered and incubated with shaking for 30 minutes. The reaction is stopped by the addition of Stop Solution (0.1M EDTA) to the wells, and the plate is read at 405-420 mm. Results are compared to the reference curve and expressed in pg/ml. Patient results are then normalized using the creatinine concentration of the sample, as measured by a separate assay.
Intended Use:
The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
Technological Characteristics of the Device Compared to Predicate Device:
The AspirinWorks Test Kit was compared to the Accumetrics® VerifyNow™ Aspirin Assay (K042423) as the predicate device. The AspirinWorks Test Kit is a competitive enzyme-linked immunoassay (ELISA) that detects 11dhTxB2 in urine. It is run in 96-well microtiter plates that have been coated with goat anti-nouse antibodies. To these wells samples, controls, or reference solution is added, followed by an 11dhTxB2alkaline phosphatase-linked tracer, and a monoclonal antibody specific for 11dhTxB2. During the two-hour incubation, the 11dhTxB2 monoclonal antibody forms a complex with either endogenous 11dhTxB2 or the 11dhTxB2 tracer, and this complex is bound to the plate by the antibodies. After washing, a substrate is added for 30 minutes, the reaction is terminated by addition of a stopping solution, and optical density at 405-420 nm is measured. The concentration of I l dhTxB2 is indirectly proportional to the amount
11575 MAIN STREET, SUITE 400 · BROOMFIELD, CO · 80020 U.S.A. PHONE: 303.457.4345 FAX: 303.453-4519 www.corgenix.com
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of yellow color measured at 405-420 mm. 11dhTxB2 is a metabolite of thromboxane A2 (TxA2), which is a potent inducer of platelet aggregation. Because TxAs has a short half-life, the more stable urinary 11dhTxB2 metabolite is used as a direct measure of concentrations of TxA2 and therefore platelet aggregation.
The Accumetrics VerifyNow Assay is a turbidimetric-based optical detection system which measures platelet-induced aggregation. The system uses the agonist arachidonic acid to induce platelet response and is based on the ability of TxAx-activated platelets to bind fibrinogen-coated beads. Light transmittance increases as activated platelets bind and aggregate the beads, and the instrument measures this change in optical signal caused by aggregation. The optical signal is measured as aspirin resistance units, or ARU (an arbitrarily assigned unit), and the normal response to aspirin results in ARU values of 1500 pg 11dhTxBy/mg creatinine) and 4/38 (10.5%) of the 325 mg/day aspirin users indicated a lack of aspirin effect. In total, 11/201 (5.5%) of all aspirin users tested indicated a lack of aspirin effect. These percentages are consistent with those in published literature for aspirin non-responsiveness or lack of aspirin effect.
Non-clinical studies show a detection range for the AspirinWorks Test Kit of 300 - 4000 pg/mL, while intraand inter-assay precision %CV's are all