(73 days)
The ACTICLOT® dPT™ is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma. This test is for in vitro diagnostic use.
ACTICLOT® dPT" is a test kit. It has three reagents that are used selectively for a screening protocol and a confirmatory protocol. LA Buffer" is used with dPT Activator" for the screening protocol. LA Phospholipids" is used with dPT Activator" for the confirmatory protocol. ACTICLOT® dPT" is a professional use qualitative test.
The provided document describes the ACTICLOT® dPT™ reagent kit, an in vitro diagnostic test for the qualitative determination of Lupus Anticoagulants (LA) in human plasma. The submission is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device (DVVtest® and DVVconfirm®). The study presented focuses on justifying this substantial equivalence rather than establishing novel acceptance criteria against a clinical gold standard.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be seen for a new device with clinical claims. Instead, it demonstrates "substantial equivalence" to a predicate device in terms of performance characteristics. The implied acceptance criterion for each category is "equivalent" to the predicate device.
| Performance Characteristic | Predicate Device Performance (DVVtest® and DVVconfirm®) | Subject Device Performance (ACTICLOT® dPT™) | Implied Acceptance Criteria for Substantial Equivalence |
|---|---|---|---|
| Precision (Intra-Assay CV) | See TABLE 3 for values (e.g., 0.3% - 3.2%) | See TABLE 2 for values (e.g., 0.5% - 3.8%) | Intra-assay CVs were within 3.8% (for subject device), similar to predicate. |
| Precision (Inter-Assay CV) | See TABLE 3 for values (e.g., 2.4% - 5.6%) | See TABLE 2 for values (e.g., 3.2% - 8.6%) | Inter-assay CVs were within 7.2% (for subject device), similar to predicate. |
| Accuracy / Method Comparison (Agreement) | Not directly stated as a single value, but inferred from the predicate's performance in accuracy matrices. | Study 1: 90.7% agreement with predicate. Study 2: 87.1% agreement with predicate. | Agreement of 87.1% to 90.7% with the predicate device. |
| Sensitivity (Detection of LA Positive Samples) | 18/23 (78.3%) LA positive samples identified. | 18/23 (78.3%) LA positive samples identified. | Identical percentage of LA positive samples identified as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
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Precision Studies:
- Sample Size: The precision studies used control samples (LAtrol® Abnormal Control and LAtrol® Normal Control). The exact number of individual measurements or replicates for each control on each instrument is not explicitly stated, but it mentions "multiple tests performed over several days."
- Data Provenance: The studies were performed by American Diagnostica Inc. and "one field trial laboratory." This indicates a mix of in-house and external testing. The country of origin for the field lab is not specified. The studies appear to be prospective, specifically designed to gather precision data for the submission.
-
Method Comparison (Accuracy) Studies:
- Sample Size:
- Study 1: 54 patient samples.
- Study 2: 93 patient samples.
- Data Provenance:
- Study 1: American Diagnostica, Inc. in Stamford, CT (USA).
- Study 2: Centre hospitalier universitaire de Sherbrooke, Fleurimont (Québec), Canada.
- The document describes testing "patient samples," which suggests these were clinical samples. It does not explicitly state if they were retrospective or prospectively collected for the study, but the context of "method comparison studies" implies they were collected and then tested with both devices.
- Sample Size:
-
Sensitivity Studies:
- Sample Size: 23 prescreened LA positive samples.
- Data Provenance: Haemotology Department at University College London, UK. These were "prescreened LA positive samples," indicating they were likely retrospective samples with established LA status used for evaluating sensitivity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Precision Studies: Ground truth was based on the assigned values of the control materials. No human experts were involved in establishing "ground truth" for the controls beyond the manufacturer's quality control processes.
- Method Comparison (Accuracy) Studies: The "ground truth" for these studies was the result obtained from the predicate device (DVVtest® and DVVconfirm®). No independent experts were used to establish a separate ground truth for LA status. The comparison was device-to-device.
- Sensitivity Studies: The samples were described as "prescreened LA positive samples." This implies that the LA positive status of these 23 samples was established prior to the study by standard clinical methods, potentially involving expert interpretation of multiple tests. However, the exact number of experts or their qualifications for this prescreening are not specified in the document.
4. Adjudication Method for the Test Set
- Precision, Accuracy, and Sensitivity Studies: The document does not describe any adjudication method (like 2+1 or 3+1 consensus) for the test results. The results appear to be direct outputs from the instruments. For the "prescreened LA positive samples" in the sensitivity study, the original method of establishing their "positive" status (which might have involved an adjudication process) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic reagent kit that provides a quantitative measurement (clotting time) which is then interpreted qualitatively as LA positive or negative. It does not involve human readers interpreting images or complex data that would typically be associated with an MRMC study.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, the studies presented are all standalone. ACTICLOT® dPT™ is a reagent kit that provides a result (clotting time) on an automated coagulation analyzer. The "performance" described refers to the output of the instrument using the reagent. The test itself is described as a "professional use qualitative test," meaning a healthcare professional interprets the result. However, the studies evaluate the reagent's performance directly on the samples, without considering the variability introduced by different human interpretations of the final qualitative call, beyond what is inherent in reporting positive/negative for LA.
7. Type of Ground Truth Used
- Precision Studies: Manufacturer-assigned values for control materials.
- Method Comparison (Accuracy) Studies: The results obtained from the predicate device (DVVtest® and DVVconfirm®).
- Sensitivity Studies: "Prescreened LA positive samples," implying existing clinical diagnosis of LA based on other methods (which could involve expert consensus, pathology, or outcomes data, but this is not detailed). The document also mentions that no single LA test identifies all LA positive samples and recommends using a combination of two or more tests. This implies that the "true" LA positivity for the 23 samples was established by a combination of tests, rather than a single definitive ground truth.
8. Sample Size for the Training Set
- This submission is for a medical device (reagent kit). There is no "training set" in the context of machine learning. The device is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable as there is no "training set" for this type of device.
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american diagnos
Creating products for life
0CT 17 2005
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K052124
Submitted by:
American Diagnostica Inc. 500 West Avenue Stamford, CT 06902 Tel. 203 602-7777 Fax 203 602-2221
Contact:
Leigh Ayres Director of Regulatory Affairs and Quality Assurance 203-602-7777 x 14 or
Clare Santulli Coagulation Manager and Field Trial Coordinator Phone: 203 602-7777 x 25
Summary Prepared:
July 26, 2005
Subject Device Information:
Catalogue number: 824
Device Name: Dilute Prothrombin Time
Proprietary/Trade name: ACTICLOT® dPT™
Common Name: LA test
Classification Name: Prothrombin Time Test
Device Classification: Class II
Regulation Number: Title 21 CFR § 864.7750
Panel: Hematology Reagents
Product Code: GJS
500 West Avenue, P.O. Box 110215, Stamford, CT. 06911-0215 Tel. (203) 602-7777 • Fax. (203) 602-2221
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Predicate Device Information:
Catalogue numbers: 810 and 815
Device Name: Dilute Russell's Viper Venom Test
Proprietary/Trade name: DVVtest" and DVVconfirm"
Common Name: LA test
Classification Name: Russell Viper Venom Reagent
Device Classification: Class I
Regulation Number: Title 21 CFR § 864.8950
Panel: Hematology Reagents
Product Code: GIR
K Number: K940490
Description of the Device:
ACTICLOT® dPT" is a test kit. It has three reagents that are used selectively for a screening protocol and a confirmatory protocol. LA Buffer" is used with dPT Activator" for the screening protocol. LA Phospholipids" is used with dPT Activator" for the confirmatory protocol. ACTICLOT® dPT" is a professional use qualitative test.
Intended Use:
The ACTICLOT* dPT" is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma. This test is for in vitro diagnostic use.
Summary of Substantial Equivalence:
ACTICLOT® dPT™ is substantially equivalent to the predicate device DVV(est" and DVVconfirm® (manufactured by American Diagnostica Inc.. Stamford. CT) in performance and intended use. This statement is based on the following criteria: intended use, methodology and test principle, operating procedures, sample requirements, reconstituted stability, specimen, precision, and accuracy from method comparison studies. The summary of substantial equivalence is shown on TABLE 1.
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TABLE 1: Summary of Substantial Equivalence for ACTICLOT® dPT" and DVViest® and DVVconfirm®
| ACTICLOT® dPT™ | DVVtest® and DVVconfirm® | |
|---|---|---|
| Intended Use | The ACTICLOT® dPT™ is intendedfor the qualitative determination oflupus anticoagulants (LA) in humanplasma. This test is for in vitrodiagnostic use | The DVVtest® and DVVconfirm® areintended for the qualitativedetermination of lupus anticoagulants(LA) in human plasma. This test is forin vitro diagnostic use. |
| Methodologyand TestPrinciple | The dPT Activator™ reagent containslipidated tissue factor and calcium.When it is mixed with LA Buffer™ inthe screening protocol, it is used toinitiate clotting in plasma and theninstrumentation is used to measure theclot time. In the confirmatoryprotocol, the dPT Activator™ and LAPhospholipids™ reagent is added toplasma and instrumentation is used todetermine clot time. | The reagent, Russell's Viper Venom,in DVVtest® is used to initiate clottingin plasma and then instrumentation isused to measure the clot time. TheRussell's Viper Venom andphospholipids in DVVconfirm® is usedto initiate clotting in plasma and theninstrumentation is used to measureclot time. |
| OperatingProcedures | Lyophilized reagents are reconstitutedprior to use and then aliquots ofreagents and plasma are combined andthen analyzed. There are nocalibrators. The kit contains reagentsand instructions for a screeningprotocol, a confirmatory protocol, andmixing studies. | The lyophilized reagents arereconstituted prior to use and thenaliquots of reagents and plasma arecombined and then analyzed. Thereare no calibrators. DVVtest® reagentis used for the screening test.DVVconfirm® reagent is used for theconfirmatory test. These two kitscontain protocols for mixing studies. |
| SampleRequirements | Blood is drawn with blood collectiontubes containing trisodium citrate andthen the tubes are centrifuged. Plasmais collected from the tubes and then itis tested. | Blood is drawn with blood collectiontubes containing trisodium citrate andthen the tubes are centrifuged. Plasmais collected from the tubes and then itis tested. |
| ReconstitutedStability | dPT Activator™ is stable for 24 hoursat 18° - 25°C.LA Buffer™ and LA Phospholipids™are stable for 10 days at 2° - 8°C or at18° -25°C. | DVVtest® and DVVconfirm® are stablefor 24 hours at 18° -25°C or 5 days at2°-8°C or 1 month at -20°C. |
| Specimen | Citrated platelet poor plasma | Citrated platelet poor plasma |
| Precision | Equivalent (See TABLE 2) | Equivalent (See TABLE 3) |
| MethodComparison(accuracy) | Equivalent (See TABLES 4 and 5) | Equivalent (See TABLES 4 and 5) |
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Precision
ACTICLOT® dPT" and DVVtest" reagent and the DVVconfirm® reagent precision studies were performed by American Diagnostica Inc. and one ficld trial laboratory using various coagulation analyzers: ACL® 300R centrifugal analyzer, BCT*, MLA* 900C coagulation analyzer, and the STA Compact". LAtrol" Abnormal Control (catalogue number 816A) and LAtrol" Normal Control (catalogue number 816N) were the controls that were tested for the precision evaluation. These precision studies included multiple tests performed over several days. The precision results from the subject device are shown in TABLE 2.
| CoagulationAnalyzer | Control | dPTScreeningmean(sec) | Intra-AssayCV (%) | Inter-AssayCV (%) | dPTConfirm-atorymean(sec) | Intra-AssayCV (%) | Inter-AssayCV (%) |
|---|---|---|---|---|---|---|---|
| ACL ® 300R | 816N | 32.8 | 2.5 | 5.1 | 30.2 | 3.8 | 5.3 |
| 816A | 63.8 | 1.9 | 7.1 | 36.9 | 3.2 | 3.8 | |
| BCT® | 816N | 47.5 | 0.5 | 3.2 | 51.6 | 1.7 | 4.5 |
| 816A | 89.2 | 0.6 | 5.2 | 61.9 | 1.2 | 3.7 | |
| MLA® 900C | 816N | 27.9 | 2.5 | 3.7 | 27.2 | 2.8 | 4.1 |
| 816A | 51.6 | 2.4 | 8.6 | 30.5 | 1.5 | 3.7 | |
| STACompact® | 816N | 40.2 | 0.8 | 3.4 | 39.7 | 0.9 | 4.3 |
| 816A | 77.9 | 1.1 | 7.2 | 46.0 | 1.0 | 4.8 |
| TABLE 2. Precision Study Results with ACTICLOT* dPT™ | |||||
|---|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------ | -- | -- |
ND -- Not Determined
The results of precision study performed with the predicate device are shown in TABLE 3.
| CoagulationAnalyzer | Control | DVVtest(sec)mean | Intra-AssayCV (%) | Inter-AssayCV (%) | DVVconfirm(sec)mean | Intra-AssayCV (%) | Inter-AssayCV (%) |
|---|---|---|---|---|---|---|---|
| ACLR 300R | 816N | 30.4 | 1.4 | ND | 31.3 | 0.6 | ND |
| 816A | 64.2 | 3.2 | ND | 35.1 | 1.4 | ND | |
| BCTR | 816N | 31.8 | 0.3 | 2.4 | 33.2 | 0.5 | 3.7 |
| 816A | 63.8 | 0.5 | 2.7 | 43.0 | 0.6 | 4.8 | |
| MLAR 900C | 816N | 31.0 | 0.9 | 2.9 | 31.7 | 1.3 | 2.3 |
| 816A | 63.6 | 1.4 | 3.9 | 34.5 | 0.9 | 3.2 | |
| STACompactR | 816N | 36.2 | 0.7 | 3.3 | 34.4 | 0.7 | 3.6 |
| 816A | 71.9 | 0.9 | 3.8 | 38.9 | 1.3 | 5.6 |
TABLE 3. Precision Study Results with DVVtest® and DVVconfirm*
Not Determined ND
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Conclusion concerning the Precision Study:
Precision data obtained from laboratory field tests and from testing at American Diagnostica Inc. show that ACTICLOT" dPT" and DVVest and DVV confirm are substantially equivalent. The precision data obtained from each instrument is substantially equivalent because the intra-assay CVs were within 3.8% and the inter-assay CVs were within 7.2%. The mean clotting times from the precision studies are shown for informational purposes only. Clotting times of the two comparative methods are not expected to be the same because both the predicate method and subject method have systematic bias''' based upon differences in mechanism of initiation of clot formation and instrument system bias in assessing clot time of each method.
Method Comparison (accuracy)
ACTICLOT* method comparison studies were performed at American Diagnostica, Inc. in Stamford, CT (Study 1) and at Centre hospitalier universitaire de Sherbrooke, Fleurimont (Québec), Canada (Study 2). Patient samples were tested using ACTICLOT® dPT" and DVVtesst" and DVVconfirm®. The accuracy matrix of each study is displayed on TABLE 4 and TABLE 5.
TABLE 4. Accuracy Matrix of Study 1
| Number of samples that wereLA positive with DVVtest Rand DVVconfirmR | Number of samples that wereLA negative with DVVtestR andDVVconfirmR | |
|---|---|---|
| Number of samples thatwere LA positive withACTICLOTR dPTTM | 17 | 5 |
| Number of samples thatwere LA negative withACTICLOTR dPTTM | 0 | 32 |
TABLE 5. Accuracy Matrix of Study 2
| Number of samples that wereLA positive with DVV test ®and DVV confirm ® | Number of samples that wereLA negative with DVV test ® andDVV confirm ® | |
|---|---|---|
| Number of samples thatwere LA positive withACTICLOT® dPT™ | 31 | 8 |
| Number of samples thatwere LA negative withACTICLOT® dPT™ | 3 | 50 |
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Conclusion Concerning the Method Comparison Studies:
The accuracy studies from the laboratory field test and from testing at American Diagnostica Inc. show that ACTICLOT * dPT" and DVV confirm are substantially equivalent. In Study 1, 49 out of 54 samples tested (90.7%) were in agreement. In Study 2, 81 out of 93 samples tested (87.1%) were in agreement. The accuracy or agreement of these two methods was between 87.1% and 90.7%.
Sensitivity Studies:
Twenty-three prescreened LA positive samples were tested at the Haemotology Department at Univeristy College London. UK with the predicate device, and a third commercially available aPTT schsitive I.A test (Dade" Actin' FSL Activated PTT Reagent). The test results are shown on TABLE 6.
| ACTICLOT® dPT™ a | DVVtest®/DVVconfirm® b | aPTT reagentb | |
|---|---|---|---|
| Number of Samplesthat Tested LAPositive with OneLA Test / Number ofLA Positive Plasmas | 18/23 | 18/23 | 19/23 |
| Percent LA Positive | 78.3% | 78.3% | 82.6% |
TABLE 6. Percent LA Positive Test Results from each of Three LA Tests
(a) Assays were performed using the ACL. 300R coagulation analyzer.
(b) Assays were performed using the Sysmex CA-1500 coagulation analyzer.
Conclusion Concerning Sensitivity:
The London study shows that the sensitivity of ACTICLOT* dPT" and DVV1est" and DVVconfirm are substantially equivalent because the subject method identified and the predicate method identified 18 of the 23 LA positive samples. The third method was included for informational purposes.
It is well known, in the haemostasis field, that no one LA test identifies all LA positive samples due to the biochemical heterogencity among lupus anticoagulants and the heterogeneity among LA test reagents 2. It is recommended that LA positive samples should be identified after testing with a combination of two or more LA tests 33. When the test results from these three methods were combined, 21 of the 23 LA positive samples were identified. The results from the combined tests are shown in TABLE 7. This increased the percent LA positive from 78.3% - 82.6% (with individual tests) to 91.3% when test results were combined.
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Percent LA Positive Test Results with Two or More LA Positive Tests from Three TABLE 7. LA Tests
| Samples tested withACTICLOT® dPT™a + DVVtest®/DVVconfirm®b + aPTT reagentb | |
|---|---|
| Number of Samplesthat Tested LAPositive with anyTwo out of ThreeLA Tests / Numberof Known LAPositive Samples | 21/23 |
| Percent LA Positive | 91.3 % |
(a) Assays were performed using the ACL 300R coagulation analyzer.
(b) Assays were performed using the Sysmex CA-1500 coagulation analyzer.
REFERENCES
- Tietz, NW. Textbook of Clinical Chemistry. Saunders. 1986: 412-413. l.
- Brandt, JT, Triplett, DA, Alving, IS, Scharrer, I. Criteria for the Diagnosis of Lupus Anticoagulants: an 2. Update. On behalf of the Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardization Committee of the ISTH. Thromb Haemost. 1995: 74(4):1185-90.
- Johns, AS, Chamley, L, Ocklford, PA, Pattison, NS, Mckay, EJ, Corkill, M. Hart, H. Comparison of 3. Tests for the Lupus Anticoagulant and Antiphopholipid Antibodies in Systemic Lupus Erythematosus. Clin Exper Rheumatol. 1994: 12: 523-6.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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OCT 17 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Leigh Ayres Director of Regulatory Affairs and Quality Assurance American Diagnostica, Inc. 500 West Avenue Stamford, Connecticut 06902
Re: K052124 Trade/Device Name: ACTICLOT® dPT™ Reagent Kit Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin time test Regulatory Class: II Product Code: GJS Dated: August 3, 2005 Received: August 5, 2005
Dear Ms. Ayres:
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 requirc 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Scction 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.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K052134 510(k) Number:
Device name: ACTICLOT® dPT™ reagent kit
Indications for Use:
The ACTICLOT® dPT™ is intended for the qualitative determination of Lupus Anticoagulants (LA) in human plasma. The test is for in vitro diagnostic use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052124
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).