(151 days)
Coatest APC Resistance V
Not Found
No
The summary describes a chemical reagent-based clotting test and does not mention any AI or ML components.
No.
The device is a diagnostic test system used for screening a genetic defect and does not provide therapy or treatment.
Yes
The device is intended for "screening of resistance to Activated Protein C in plasma from individuals with the Factor V (Leiden) defect," which is a diagnostic purpose to identify a particular condition.
No
The device description explicitly states it is a lyophilized paired reagent, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "functional clotting test system intended for screening of resistance to Activated Protein C in plasma from individuals..." This indicates it's used to test samples taken from the human body (plasma) in vitro (outside the body) to provide information about a medical condition (Factor V Leiden defect).
- Device Description: The description mentions "lyophilized paired reagent containing... venom and... time reagent." These are components used to perform a test on a biological sample.
- Intended User / Care Setting: It's intended for "Clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
- Performance Studies: The description of performance studies details how the device was evaluated using plasma samples from individuals to determine its accuracy in identifying Factor V Leiden status. This is characteristic of the evaluation of an IVD.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Device Intended Use: OrialDoron - 15 a smillion with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.
Indications For Use: GradiLeiden V is a simple functional clotting test system intended for sceening of resistance to Activated Protein C in plasma from individuals with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.
Product codes (comma separated list FDA assigned to the subject device)
GGW
Device Description
The GradiLeiden V Test is a lyophilized paired reagent containing 5 vials of whole diluted Agkistrodon contortrix venom and 5 vials of phospholipid rich Russell's Viper Venom time reagent.
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
Clinical laboratories
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
GradiLeiden V was compared against the predicate device in a series of clotting assays, with all results confirmed by DNA analysis. Using a cut-off of 1.57 obtained by ROC analysis, Gradil.eiden V correctly identified the Factor V Leiden status of 163/164 individuals (82 negative). These included 35/36 Oral Anticoagulated plasmas, 21/21 heparinised plasmas and 12/12 Lupus Anticoagulant positive plasmas. GradiLeiden V was tested using the Stago STA, Dade Behring BCS, Organon Teknika MDA180 and manual tilt tube technique.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
GradiLeiden V was compared against the predicate device in a series of clotting assays, with all results confirmed by DNA analysis. Using a cut-off of 1.57 obtained by ROC analysis, Gradil.eiden V correctly identified the Factor V Leiden status of 163/164 individuals (82 negative). These included 35/36 Oral Anticoagulated plasmas, 21/21 heparinised plasmas and 12/12 Lupus Anticoagulant positive plasmas. GradiLeiden V was tested using the Stago STA, Dade Behring BCS, Organon Teknika MDA180 and manual tilt tube technique. The test was found to have 100% sensitivity and 98.8% specificity at a cut-off of 1.57 determined by ROC analysis.
Total precision estimates for FVL+, borderline normal, and normal plasma are 8.9%, 1.6%, and 5.6%, respectively. Within run precision estimates for FVL+ and normal plasma are 1.1% and 1.9%. Within run precision at the cutoff is 0.9%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% sensitivity and 98.8% specificity at a cut-off of 1.57 determined by ROC analysis.
Total precision estimates for FVL+, borderline normal, and normal plasma are 8.9%, 1.6%, and 5.6%, respectively. Within run precision estimates for FVL+ and normal plasma are 1.1% and 1.9%. Within run precision at the cutoff is 0.9%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Coatest APC Resistance V
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
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510(k) Summary
GradiLeiden V Test
The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;
Submitter's Name: Gradipore Ltd
Submitter's Address: Lot 16 Riverside Corporate Park 35 - 105 Delhi Rd, North Ryde 2113 Australia
Submitter's Telephone: 1800 762 2620
Submitter's Contact: Rhonda Pilgrim Regulatory Affairs Manager
Date 510(k) Summary Prepared: 21 July, 1999
The name of the device, including the trade or proprietary name if applicable, the common (a)(2) or usual name, and the classification name, if known;
Trade or Proprietary Name: GradiLeiden V
Common or Usual Name: APC Resistance Test
Classification Name: Hematology
An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence;
Device Equivalent to: Coatest APC Resistance V
A description of the device. (a)(4)
Device Description: The GradiLeiden V Test is a lyophilized paired reagent containing 5 vials of whole diluted Agkistrodon contortrix venom and 5 vials of phospholipid rich Russell's Viper Venom time reagent.
A statement of the intended use of the device. (a)(5)
Device Intended Use:
Device Intended Use. OrialDoron - 15 a smillion with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.
Image /page/0/Picture/22 description: The image contains the words "Gradipore ORIGINAL (if in red)". The text is in a sans-serif font and is black on a white background. The text is slightly blurry and pixelated.
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GRADILEIDEN V 510(k) Submission July, 1999
A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device.
GradiLeiden V is a clotting test based on lyophilised Russell's Viper Venom, which activates clotting at Factor X in the common pathway, while the Coatest APC Resistance V test is a clotting test based on an APTT system. The Factor V Leiden mutation affects Factor V in the common pathway, so both clotting tests are equally sensitive to the defect.
GradiLeiden V uses a lyophilised snake venom to activate the patient's own protein C while the Coatest APC Resistance V test uses lyophilised purified activated protein C.
Both tests can be automated in 2 stage clotting test systems with similar activation and acquisition times.
GradiLeiden V does not require dilution of plasma samples as the test is insensitive to heparin, Lupus Anticoagulants and to factor deficiencies caused by oral anticoagulants. Coatest APC Resistance V test requires dilution of patient samples in Factor V depleted plasma in order to eliminate sensitivity to heparin, Lupus Anticoagulants and oral anticoagulants.
A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency.
GradiLeiden V and Coatest APC Resistance V test both have the same intended use and can be used with the same patient groups. Both tests are automatable two stage clotting tests, wherein a blank test and a test in which either APC (Coatest APC Resistance V) or Venom activator (GradiLeiden V) are compared and a ratio obtained. The normal range for this ratio in both tests is reported as approximately 2-3. While both tests can be used for patients on oral anticoagulant or heparin therapy and for Lupus Anticoagulant positive patients. GradiLeiden V does not require plasma dilution while the Coatest APC Resistance V does. Within run precision for both tests is less than 5%.
A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket (b)(2) notification submission for a determination of substantial equivalency.
GradiLeiden V was compared against the predicate device in a series of clotting assays, with all results confirmed by DNA analysis. Using a cut-off of 1.57 obtained by ROC analysis, Gradil.eiden V correctly identified the Factor V Leiden status of 163/164 individuals (82 negative). These included 35/36 Oral Anticoagulated plasmas, 21/21 heparinised plasmas and 12/12 Lupus Anticoagulant positive plasmas. GradiLeiden V was tested using the Stago STA, Dade Behring BCS, Organon Teknika MDA180 and manual tilt tube technique. The test was found to have 100% sensitivity and 98.8% specificity at a cut-off of 1.57 determined by ROC analysis.
Total precision estimates for FVL+, borderline normal, and normal plasma are 8.9%, 1.6%, and 5.6%, respectively. Within run precision estimates for FVL+ and normal plasma are 1.1% and 1.9%. Within run precision at the cutoff is 0.9%
(b)3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
Gradipore Ltd considers GradiLeiden V to be substantially equivalent to the Chromogenix AB Coatest APC Resistance V Test in terms of intended use, method comparison and overall performance characteristics.
Image /page/1/Picture/13 description: The image shows the words "Gradipore ORIGINAL (if in red)" in a bold, sans-serif font. The words are stacked on top of each other, with "Gradipore" on the top line, "ORIGINAL" on the second line, and "(if in red)" on the third line. The text is black and the background is white. The text appears to be part of a label or document.
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GRADILEIDEN V 510(k) Submission July, 1999
17.0 QUALITY ASSURANCE/QUALITY CONTROL
The following is Gradipore Ltd's recommended quality control for the use of GradiLeiden V Test in clinical laboratories:
Each laboratory should establish its own normal range and abnormal range for each lot of GradiLeiden V Test reagent.
The use of control plasma is recommended for monitoring coagulation assays following established laboratory quality control procedures. NCCLS recommends controls be assayed at the initiation of testing, at least once each shift, or with each group of assays. In high volume laboratories, controls should be tested with at least every 40 samples, as per NCCLS tentative guidelines H28-T, 1992.
If control values are out of range, do not report patient results. Determine which part of the instrument/reagent/control system is not functioning properly and correct it. After corrective measures are implemented and documented following good laboratory practice, retest the controls. If they are within range, patient samples can be tested and reported.
Image /page/2/Picture/6 description: The image shows the words "Gradipore ORIGINAL (if in red)" stacked on top of each other. The word "Gradipore" is at the top, followed by the word "ORIGINAL" in a slightly larger font. The phrase "(if in red)" is at the bottom in a smaller font. The text appears to be slightly distressed or textured.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 1999
Ms. Rhonda Pilgrim M.SC. Regulatory Affairs Manager Gradipore Ltd. Haemostasis Lot 16 Riverside Corporate Park 35 – 105 Delhi Road North Ryde 2113 Australia
Re: K992456 Trade Name: GradiLeiden V Test Regulatory Class: II Product Code: GGW Dated: November 10, 1999 Received: November 17, 1999
Dear Ms. Pilgrim:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, listing 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
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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GRADILEIDEN V 510(k) Sudmissium July, 1999
18.0 INTENDED USE STATEMENT
510(k) Number (If known): K992456
Device Name: GradiLeiden V Test
Indications For Use:
GradiLeiden V is a simple functional clotting test system intended for sceening of resistance to Gradil eiden V is a smillional cloiding cloridize with the Factor V (Leiden) defect. It can also be
Activated Protein C in plasma from individuals with the Factor V (Leidene Activated Protein C in plasma from marrialians was more anticoagulant or heparin therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K952456 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| (Optional Format 1-2-96) |
Image /page/5/Picture/8 description: The image shows the words "Gradipore ORIGINAL (if in red)" stacked on top of each other. The words are in a bold, sans-serif font. The words are slightly distorted, as if they were printed on a textured surface. The words are all in black ink.