(323 days)
K925433 Stachrom® HEPARIN ASSAY KIT
Not Found
No
The description details a chemical and optical detection method for measuring clotting time, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is a diagnostic test kit used to detect the anticoagulant effects of enoxaparin in blood. It provides information for clinicians but does not directly treat or mitigate a disease.
Yes
The device is described as a "qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects... of enoxaparin sodium" and provides "information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time." This directly relates to the diagnosis or monitoring of a patient's condition (anticoagulant effects).
No
The device description clearly states it is a "one-step dry coagulation method performed on the RapidPoint Coag analyzer" and includes a "test card formulation" with physical components like "purified Factor Xa activator, calcium, phospholipid and stabilizers" and "Paramagnetic iron oxide particles". This indicates a hardware component (the analyzer) and a physical consumable (the test card) are integral to the device's function, making it a hardware-based medical device with associated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects... in arterial citrated whole blood from patients...". This describes a test performed on a biological sample (whole blood) to provide information about a patient's condition (anticoagulant effects of enoxaparin).
- Device Description: The device description details a "one-step dry coagulation method performed on the RapidPoint Coag analyzer" that uses reagents to measure clotting time in a patient sample. This is consistent with the definition of an in vitro diagnostic test.
- Sample Type: The test uses "arterial citrated whole blood from patients," which is a biological specimen.
- Purpose: The test provides "information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time," which is used to aid in clinical decision-making.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rapidpoint™Coag Enoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, ≥ 1.0 IU/ml, of the low molecular weight heparin (LMWH), Lovenox®/Clexane® (enoxaparin sodium)¹, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.0 IU/ml and the absence of drug.
The test provides information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician
Product codes (comma separated list FDA assigned to the subject device)
KFF
Device Description
The RapidPoint Enoxaparin (ENOX) test is a one-step dry coagulation method performed on the RapidPoint Coag analyzer. All of the components necessary to perform the assay, with the exception of patient sample, are included in the reaction chamber of the test card.
In the ENOX test, factor X is rapidly converted to factor Xa by a specific factor X activator initiating the clotting process. Enoxaparin, from the patient's blood, complexes with antithrombin (AT), to inhibit factor Xa and lengthen the clotting time. Reported clotting times in excess of the assay cut-off indicate an enoxaparin concentration greater than or equal to 1.0 International Units per milliliter. The results generated by the ENOX test are indicative of the anticoagulant effect produced by enoxaparin in citrated arterial whole blood.
The test card formulation contains purified Factor Xa activator, calcium, phospholipid and stabilizers. Paramagnetic iron oxide particles (PIOP) are included to provide an optical detection mechanism in the presence of patient sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
either the point of care or in the central laboratory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
88 patients. The trial was conducted at 6 sites in the United States and included 27 females (31%). The mean age of the population was 61.3 years, and the mean weight was 87.3 kg. The study cohort received enoxaparin for a primary indication of coronary artery disease. All patients received a weight-adjusted dose of 0.75mg/kg IV. Samples were tested in duplicate, and the first sample was used for final analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IN-HOUSE DATA:
Reproducibility: Reproducibility studies performed using citrated plasma with and without the addition of 1.0 (anti-Xa) IU/ml enoxaparin produced the following ENOX test results.
Enoxaparin concentration (anti-Xa IU/ml): 0.0 -
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).
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510(k) Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
The assigned 510(k) number is K013305
- Patrick D. Mize, Ph.D. (author) Submitted by: Pharmanetics, Inc. (Cardiovascular Diagnostics, Inc.)
- 9401 Globe Center Drive Address: Suite 140 Morrisville, NC 27560
Phone: 1-800-247-4234
Fax: 1-919-582-2601
- Contact: Laura Nea Director Quality Assurance
Date of Summary: August 22, 2002
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Trade name: Thrombolytic Assessment System (TAS) or Rapidpoint™ Coag Enoxaparin (ENOX) Test Card
Common Name: ENOX Test Card
Classification Name: CFR Section 21 CFR 864.7525 Class II
Predicate Device: K925433 Stachrom® HEPARIN ASSAY KIT
Description of the Device:
The RapidPoint Enoxaparin (ENOX) test is a one-step dry coagulation method performed on the RapidPoint Coag analyzer. All of the components necessary to perform the assay, with the exception of patient sample, are included in the reaction chamber of the test card.
In the ENOX test, factor X is rapidly converted to factor Xa by a specific factor X activator initiating the clotting process. Enoxaparin, from the patient's blood, complexes with antithrombin (AT), to inhibit factor Xa and lengthen the clotting time. Reported clotting times in excess of the assay cut-off indicate an enoxaparin concentration greater than or equal to 1.0 International Units per milliliter. The results generated by the ENOX test are indicative of the anticoagulant effect produced by enoxaparin in citrated arterial whole blood.
The test card formulation contains purified Factor Xa activator, calcium, phospholipid and stabilizers. Paramagnetic iron oxide particles (PIOP) are included to provide an optical detection mechanism in the presence of patient sample.
Intended Use
The Rapidpoint™ Coag Enoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, ≥1.0 IU/mL, of the low molecular weight heparin (LMWH), Lovenox®/Clexane® (enoxaparin sodium)', in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use either at the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.0 IU/ml and the absence of drug.
The test provides information on the patient's arterial citrated whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician.
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The ENOX Test is optimized to detect the effects of enoxaparin only. The use of the ENOX test to monitor unfractionated heparin (UFH) or other low molecular weight heparins (LMWH) is contraindicated due to the different clot signatures or responses produced by each of these compounds. ENOX test results have only been validated for use in detecting the effect of enoxaparin in citrated arterial whole blood. Unfractionated heparin interferes with this test.
For in vitro diagnostic use only.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Device | Stachrom Heparin Assay | Rapidpoint ENOX Test |
| Intended Use | Determines heparin or LMWH | |
| concentration | Detects arterial citrated whole | |
| blood anticoagulant effect of | ||
| enoxaparin (a LMWH) | ||
| Format | Chromogenic [colorimetric] | |
| assay | Dried reagents in reaction | |
| chamber on flat test card | ||
| Reaction | Two-stage chemical | One-stage clotting |
| Sample type | Plasma | Arterial citrated whole blood |
| Reagent base | Antithrombin (AT), factor Xa, | |
| chromogenic substrate | Factor X activator, | |
| phospholipid, calcium chloride, | ||
| PIOP | ||
| Reaction | Heparin in plasma complexes | |
| with AT to inactivate added | ||
| factor Xa. Remaining factor Xa | ||
| catalyzes release of p- | ||
| nitroaniline from the substrate; | ||
| Color formation is inversely | ||
| proportional to heparin level | Enoxaparin (LMWH) in blood | |
| complexes with AT to | ||
| inactivate factor Xa. Factor X | ||
| activator converts factor X to | ||
| factor Xa, initiating clotting | ||
| process. Clot formation time is | ||
| related to enoxaparin (LMWH) | ||
| concentration. | ||
| Instrument | Spectrophotometer | RapidPoint Coag (TAS) |
| Endpoint monitored | Colorimetric reaction; | |
| Absorbance at 405 nm | Clot formation process. | |
| Clotting time in seconds | ||
| Test interpretation | Heparin or LMWH | |
| concentration | Qualitative. Enoxaparin > 1.0 | |
| IU/ml Anti Xa gives clot times | ||
| in arterial citrated whole blood |
260 Secs. Clot times 55% may cause elongated clotting times and should be interpreted with caution.
Deficiencies in factors X, V, and prothrombin could result in a prolongation of the ENOX clotting test result even in the absence of enoxaparin in the sample. In the presence of enoxaparin, a deficiency in these factors would reflect both enoxaparin effect and prolongation caused by the deficient factor(s). Drugs that affect clotting factors in the common pathway (e.g. coumadin), including factors X, V, prothrombin and fibrinogen can affect ENOX clotting times. No testing has been performed on clinical samples with an International Normalized Ratio (INR) above 1.4.
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CLINICAL Studies
Data were obtained from a clinical trial comparing arterial citrated whole blood clot times using the ENOX card versus central laboratory measured plasma anti-Xa levels, Citrated whole blood arterial samples were collected at baseline and at peak values (within 15 minutes of dosing) after enoxaparin administration among 88 patients. The trial was conducted at 6 sites in the United States and included 27 females (31%). The mean age of the population was 61.3 years, and the mean weight was 87.3 kg. The study cohort received enoxaparin for a primary indication of coronary artery disease. All patients received a weight-adjusted dose of 0.75mg/kg IV. Samples were tested in duplicate, and the first sample was used for final analysis. The relationship between clotting time cutoff (260 secs) and 1.0 IU/ml anti-Xa value from the clinical trial data is presented in the following table.
Number of Subjects Above and Below ENOX Cutoff of 260 seconds:
| Time/anti-Xa
Concentration | anti-Xa ≥1.0 IU | anti-Xa 260 secs. The x-axis shows clot time, ranging from 0 to 600.
Frequency distribution of patients' ENOX card clotting times for citrated arterial whole blood samples, before and after the IV administration of Enoxaparin. The 88 patients were candidates for coronary intervention and were treated with 0.75mg/kg enoxaparin IV. Samples containing drug were obtained within 15 minutes of drug administration.
In summary, the test provides information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method. Results above the cutoff are consistent with values greater than or equal to 1.0 IU/ml of enoxaparin. The results should be interpreted in conjunction with other clinical information available to the clinician. Unexpected results should be verified with an alternative diagnostic method.
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Statement of Substantial Equivalence
The TAS ENOX card has been shown to be substantially equivalent to the predicate device, STACHROM® Heparin Assay, in performance, intended use and safety and effectiveness, for the qualitative determination of > 1.0 IU/ml (anti –Xa activity) of enoxaparin in arterial citrated whole blood.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2002
Ms. Laura P. Nea Director, Quality Assurance PharmaNetics, Inc. Cardiovascular Diagnostics, Inc.(CVDI) 9401 Globe Center Drive - Suite #140 Morrisville, North Carolina 27560
Re: K013305
Trade/Device Name: TAS ™ Enoxaparin (ENOX)™ Test Card Regulation Number: 21 CFR 864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF Dated: July 18, 2002 Received: July 19, 2002
Dear Ms. Nea:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K013305
Device Name: Enoxaparin (ENOX) Test Card
Indications for Use:
The Rapidpoint™Coag Enoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, ≥ 1.0 IU/ml, of the low molecular weight heparin (LMWH), Lovenox®/Clexane® (enoxaparin sodium)¹, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.0 IU/ml and the absence of drug.
The test provides information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician
Jasshine Bautista
(Division/Sign-Off)
Wision of Clinical Laboratory Devices
510(k) Number K013305
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)