(141 days)
AMAX 190™ Coagulation Analyzer
Not Found
No
The description focuses on standard coagulation testing methods (mechanical, photo-optical, chromogenic, agglutination) and performance metrics (regression, precision) without mentioning any AI/ML terms or functionalities.
No
The device is an in vitro diagnostic (IVD) system used for coagulation studies and factor assays, which are diagnostic tests and not therapeutic interventions.
Yes
The device performs in vitro coagulation studies and factor assays, which are used to detect conditions like fibrin formation, and measure specific substances (e.g., antithrombin III, d-dimer) in patient samples, indicating its role in diagnosis.
No
The device description explicitly states it is an "automated instrument" and an "automated random access multipurpose analyzer," indicating it is a hardware device with associated software.
Yes, the AMAX Destiny™ Coagulation Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is used "for in vitro coagulation studies." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVD devices.
- Device Description: The description details how the device performs tests on samples (blood or plasma) using various methods (mechanical, photo-optical, chromogenic, microparticle agglutination). These tests are performed on biological samples outside the patient's body to provide information about their health status.
- Performance Studies: The performance studies describe comparisons and precision testing of assays performed by the device. This type of testing is standard for validating the performance of IVD devices.
The definition of an IVD device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The AMAX Destiny™ Coagulation Analyzer fits this description by performing tests on biological samples to assess coagulation, which is crucial for diagnosing and managing various health conditions.
N/A
Intended Use / Indications for Use
The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Product codes
JPA
Device Description
The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.
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
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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
In comparison studies of assays between the AMAX Destiny™ Coagulation Analyzer and the AMAX 190™ Coagulation Analyzer, the following regression statistics were obtained:
PT (optical): r = 0.993, y = 1.223x - 1.5
PT (mechanical): r = 0.994, y = 1.180x - 2.5
APTT (optical): r = 0.913, y = 1.191x - 1.2
APTT (mechanical): r = 0.923, y = 1.112x - 2.3
Factor IX (optical): r = 0.977, y = 0.928x + 3.8
Factor IX (mechanical): r = 0.964, y = 0.880x + 3.9
Factor X (optical): r = 0.982, y = 0.935x + 3.3
Factor X (mechanical): r = 0.972, y = 0.957x + 2.5
Fibrinogen (optical): r = 0.978, y = 0.974x + 27.3
Fibrinogen (mechanical): r = 0.968, y = 1.069x - 14.5
Thrombin time (mechanical): r = 0.990, y = 0.965x + 1.5
AT III (chromogenic): r = 0.934, y = 1.070x - 8.8
D-dimer (agglutination): r = 0.995, y = 1.121x - 57.0
The following coefficients of variation were obtained from precision studies:
PT (optical): Within Run
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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510(k) NOTIFICATION
Sigma Diagnostics Inc. March 13, 2002
| 510(k) Summary of Safety and Effectiveness | K021162 | |
|---|---|---|
| Submitted by: | Sigma Diagnostics | |
| 545 South Ewing Av | ||
| St. Louis, MO 63103 | AUG 3 0 2002 | |
| Contact Person: | William R. Gilbert, Ph.D. | |
| Manager, Scientific Affairs | ||
| 314-286-6693 | ||
| Preparation Date: | July 12, 2002 | |
| Device Name: | AMAX Destiny™ Coagulation Analyzer | |
| Device Classification: | JPA, Multipurpose system for in vitro coagulation studies, Class II | |
| (864 5425) |
The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.
In comparison studies of assays between the AMAX Destiny™ Coagulation Analyzer and the AMAX 190™ Coagulation Analyzer, the following regression statistics were obtained:
| PT (optical) | r = 0.993 | y = 1.223x - 1.5 |
|---|---|---|
| PT (mechanical) | r = 0.994 | y = 1.180x - 2.5 |
| APTT (optical) | r = 0.913 | y = 1.191x - 1.2 |
| APTT (mechanical) | r = 0.923 | y = 1.112x - 2.3 |
| Factor IX (optical) | r = 0.977 | y = 0.928x + 3.8 |
| Factor IX (mechanical) | r = 0.964 | y = 0.880x + 3.9 |
| Factor X (optical) | r = 0.982 | y = 0.935x + 3.3 |
| Factor X (mechanical) | r = 0.972 | y = 0.957x + 2.5 |
| Fibrinogen (optical) | r = 0.978 | y = 0.974x + 27.3 |
| Fibrinogen (mechanical) | r = 0.968 | y = 1.069x - 14.5 |
| Thrombin time (mechanical) | r = 0.990 | y = 0.965x + 1.5 |
| AT III (chromogenic) | r = 0.934 | y = 1.070x - 8.8 |
| D-dimer (agglutination) | r = 0.995 | y = 1.121x - 57.0 |
1
Sigma Diagnostics Inc. March 13, 2002
The following coefficients of variation were obtained from precision studies:
| Within Run | Total | |
|---|---|---|
| PT (optical) | Trade/Device Name: AMAX Destiny™ Coagulation Analyzer Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: July 12, 2002 Received: July 16, 2002 |
Dear Dr. Gilbert:
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, 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 (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 (QS) 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 Sutman
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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510(k) Number (if known): __ KOAII (62
Device Name: AMAX Destiny™ Coagulation Analyzer
Indications For Use:
The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Josephine. Bantler.
(Divisibri Sidh-Off) Division of Clinical Laboratory Devices 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________