(73 days)
Not Found
No
The device description and performance studies focus on a reagent-based in vitro diagnostic test kit and its analytical performance, with no mention of AI or ML algorithms.
No.
This device is an in vitro diagnostic test intended for the qualitative determination of lupus anticoagulants (LA) in human plasma, not for therapeutic use.
Yes.
The device is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma, which is a diagnostic purpose. The description explicitly states "This test is for in vitro diagnostic use."
No
The device description clearly states it is a "test kit" with "three reagents," indicating it is a physical product containing chemical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first line explicitly states: "This test is for in vitro diagnostic use."
- Device Description: It describes the device as a "test kit" used for the "qualitative determination of lupus anticoagulants (LA) in human plasma." This clearly indicates it's used to analyze biological samples outside of the body for diagnostic purposes.
- Anatomical Site and Input Imaging Modality: The descriptions for these fields are "Not Applicable (In vitro diagnostic test)," further reinforcing its nature as an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
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.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision studies:
Performed by American Diagnostica Inc. and one field trial laboratory using various coagulation analyzers: ACL® 300R centrifugal analyzer, BCT*, MLA* 900C coagulation analyzer, and the STA Compact". Controls used were LAtrol" Abnormal Control (catalogue number 816A) and LAtrol" Normal Control (catalogue number 816N).
Key results: Intra-assay CVs were within 3.8% and inter-assay CVs were within 7.2%.
Method Comparison (accuracy) studies:
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®.
Study 1: 49 out of 54 samples tested (90.7%) were in agreement.
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).
ACTICLOT® dPT™ identified 18/23 (78.3%) of LA positive samples.
DVVtest®/DVVconfirm® identified 18/23 (78.3%) of LA positive samples.
aPTT reagent identified 19/23 (82.6%) of LA positive samples.
When test results from these three methods were combined, 21 of the 23 LA positive samples were identified (91.3%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: Intra-assay CVs were within 3.8% and inter-assay CVs were within 7.2%.
Accuracy (Agreement): Between 87.1% and 90.7%.
Sensitivity: 78.3% (individual test for ACTICLOT® dPT™ and DVVtest®/DVVconfirm®).
Sensitivity (Combined Tests): 91.3% when ACTICLOT® dPT™, DVVtest®/DVVconfirm®, and aPTT reagent results were combined.
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.
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
§ 864.7750 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).
0
Image /page/0/Picture/0 description: The image shows a stylized American flag design. The flag's stripes are represented by solid black bars. In the upper left corner, where the stars would typically be, there is the text "ai" with a square and diamond symbol above it. The text and symbols are white, contrasting with the black stripes.
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
1
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.
2
TABLE 1: Summary of Substantial Equivalence for ACTICLOT® dPT" and DVViest® and DVVconfirm®
| ACTICLOT® dPT™ | DVVtest® and DVVconfirm® | |
|---|---|---|
| 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 | The DVVtest® and DVVconfirm® are | |
| intended for the qualitative | ||
| determination of lupus anticoagulants | ||
| (LA) in human plasma. This test is for | ||
| in vitro diagnostic use. | ||
| Methodology | ||
| and Test | ||
| Principle | The dPT Activator™ reagent contains | |
| lipidated tissue factor and calcium. | ||
| When it is mixed with LA Buffer™ in | ||
| the screening protocol, it is used to | ||
| initiate clotting in plasma and then | ||
| instrumentation is used to measure the | ||
| clot time. In the confirmatory | ||
| protocol, the dPT Activator™ and LA | ||
| Phospholipids™ reagent is added to | ||
| plasma and instrumentation is used to | ||
| determine clot time. | The reagent, Russell's Viper Venom, | |
| in DVVtest® is used to initiate clotting | ||
| in plasma and then instrumentation is | ||
| used to measure the clot time. The | ||
| Russell's Viper Venom and | ||
| phospholipids in DVVconfirm® is used | ||
| to initiate clotting in plasma and then | ||
| instrumentation is used to measure | ||
| clot time. | ||
| Operating | ||
| Procedures | Lyophilized reagents are reconstituted | |
| prior to use and then aliquots of | ||
| reagents and plasma are combined and | ||
| then analyzed. There are no | ||
| calibrators. The kit contains reagents | ||
| and instructions for a screening | ||
| protocol, a confirmatory protocol, and | ||
| mixing studies. | The lyophilized reagents are | |
| reconstituted prior to use and then | ||
| aliquots of reagents and plasma are | ||
| combined and then analyzed. There | ||
| are no calibrators. DVVtest® reagent | ||
| is used for the screening test. | ||
| DVVconfirm® reagent is used for the | ||
| confirmatory test. These two kits | ||
| contain protocols for mixing studies. | ||
| Sample | ||
| Requirements | Blood is drawn with blood collection | |
| tubes containing trisodium citrate and | ||
| then the tubes are centrifuged. Plasma | ||
| is collected from the tubes and then it | ||
| is tested. | Blood is drawn with blood collection | |
| tubes containing trisodium citrate and | ||
| then the tubes are centrifuged. Plasma | ||
| is collected from the tubes and then it | ||
| is tested. | ||
| Reconstituted | ||
| Stability | dPT Activator™ is stable for 24 hours | |
| at 18° - 25°C. | ||
| LA Buffer™ and LA Phospholipids™ | ||
| are stable for 10 days at 2° - 8°C or at | ||
| 18° -25°C. | DVVtest® and DVVconfirm® are stable | |
| for 24 hours at 18° -25°C or 5 days at | ||
| 2°-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) |
| Method | ||
| Comparison | ||
| (accuracy) | Equivalent (See TABLES 4 and 5) | Equivalent (See TABLES 4 and 5) |
500 West Avenue, P.O. Box 110215, Stamford, CT. 06911-0215 Tel. (203) 602-7777 • Fax. (203) 602-2221 Page 3 of 7
3
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.
| Coagulation
Analyzer | Control | dPT
Screening
mean
(sec) | Intra-
Assay
CV (%) | Inter-
Assay
CV (%) | dPT
Confirm-
atory
mean
(sec) | Intra-
Assay
CV (%) | Inter-
Assay
CV (%) |
|-------------------------|---------|-----------------------------------|---------------------------|---------------------------|-------------------------------------------|---------------------------|---------------------------|
| 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 |
| STA
Compact® | 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.
| Coagulation
Analyzer | Control | DVVtest
(sec)
mean | Intra-
Assay
CV (%) | Inter-
Assay
CV (%) | DVV
confirm
(sec)
mean | Intra-
Assay
CV (%) | Inter-
Assay
CV (%) |
|-------------------------|---------|--------------------------|---------------------------|---------------------------|---------------------------------|---------------------------|---------------------------|
| 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 |
| STA
CompactR | 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
500 West Avenue, P.O. Box 110215, Stamford, CT. 06911-0215 Tel. (203) 602-7777 • Fax. (203) 602-2221 Page 4 of 7
4
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 were
LA positive with DVVtest R
and DVVconfirmR | Number of samples that were
LA negative with DVVtestR and
DVVconfirmR |
|--------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Number of samples that
were LA positive with
ACTICLOTR dPTTM | 17 | 5 |
| Number of samples that
were LA negative with
ACTICLOTR dPTTM | 0 | 32 |
TABLE 5. Accuracy Matrix of Study 2
| | Number of samples that were
LA positive with DVV test ®
and DVV confirm ® | Number of samples that were
LA negative with DVV test ® and
DVV confirm ® |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Number of samples that
were LA positive with
ACTICLOT® dPT™ | 31 | 8 |
| Number of samples that
were LA negative with
ACTICLOT® dPT™ | 3 | 50 |
500 West Avenue, P.O. Box 110215, Stamford, CT. 06911-0215 Tel. (203) 602-7777 • Fax. (203) 602-2221 Page 5 of 7
5
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 Samples | |||
| that Tested LA | |||
| Positive with One | |||
| LA Test / Number of | |||
| LA 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.
6
Percent LA Positive Test Results with Two or More LA Positive Tests from Three TABLE 7. LA Tests
| | Samples tested with
ACTICLOT® dPT™a + DVVtest®/DVVconfirm®b + aPTT reagentb |
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Number of Samples
that Tested LA
Positive with any
Two out of Three
LA Tests / Number
of Known LA
Positive 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
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of what appears to be an eagle.
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.
8
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
9
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