(141 days)
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.
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.
The provided document is a 510(k) summary for the AMAX Destiny™ Coagulation Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (AMAX 190™ Coagulation Analyzer) through performance comparisons, specifically regression statistics and precision studies. Since this is a submission for an in-vitro diagnostic device (an analyzer), the typical acceptance criteria and study designs for imaging AI/ML devices (which involve human readers, ground truth establishment by experts, etc.) are not directly applicable.
However, I will extract relevant information and reframe it to align with the spirit of your request to the best of my ability, highlighting what "acceptance criteria" and "study" mean in this context.
1. Table of Acceptance Criteria and Reported Device Performance
For this in-vitro diagnostic device, "acceptance criteria" are implicitly defined by the demonstration of "substantial equivalence" to the predicate device, the AMAX 190™ Coagulation Analyzer. The performance metrics are regression statistics (correlation coefficient 'r' indicating linearity/agreement, and the regression equation 'y = mx + b' indicating bias and slope) and precision (within-run and total coefficients of variation).
| Test | Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|---|
| PT (optical) | Correlation (r) | High correlation (e.g., typically >0.9) | 0.993 |
| PT (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.223x - 1.5 |
| PT (mechanical) | Correlation (r) | High correlation | 0.994 |
| PT (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.180x - 2.5 |
| APTT (optical) | Correlation (r) | High correlation | 0.913 |
| APTT (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.191x - 1.2 |
| APTT (mechanical) | Correlation (r) | High correlation | 0.923 |
| APTT (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.112x - 2.3 |
| Factor IX (optical) | Correlation (r) | High correlation | 0.977 |
| Factor IX (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.928x + 3.8 |
| Factor IX (mechanical) | Correlation (r) | High correlation | 0.964 |
| Factor IX (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.880x + 3.9 |
| Factor X (optical) | Correlation (r) | High correlation | 0.982 |
| Factor X (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.935x + 3.3 |
| Factor X (mechanical) | Correlation (r) | High correlation | 0.972 |
| Factor X (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.957x + 2.5 |
| Fibrinogen (optical) | Correlation (r) | High correlation | 0.978 |
| Fibrinogen (optical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.974x + 27.3 |
| Fibrinogen (mechanical) | Correlation (r) | High correlation | 0.968 |
| Fibrinogen (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.069x - 14.5 |
| Thrombin time (mechanical) | Correlation (r) | High correlation | 0.990 |
| Thrombin time (mechanical) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 0.965x + 1.5 |
| AT III (chromogenic) | Correlation (r) | High correlation | 0.934 |
| AT III (chromogenic) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.070x - 8.8 |
| D-dimer (agglutination) | Correlation (r) | High correlation | 0.995 |
| D-dimer (agglutination) | Regression (y=mx+b) | Slope near 1, intercept near 0 | y = 1.121x - 57.0 |
| Precision Studies - Within Run Coefficient of Variation | Typically <10% (application dependent) | ||
| PT (optical) | CV | < 2.0% | <2.0% |
| PT (mechanical) | CV | < 1.2% | <1.2% |
| APTT (optical) | CV | < 1.4% | <1.4% |
| APTT (mechanical) | CV | < 1.3% | <1.3% |
| Factor IX (optical) | CV | < 4.4% | <4.4% |
| Factor IX (mechanical) | CV | < 4.3% | <4.3% |
| Factor X (optical) | CV | < 3.0% | <3.0% |
| Factor X (mechanical) | CV | < 4.7% | <4.7% |
| Fibrinogen (optical) | CV | < 2.3% | <2.3% |
| Fibrinogen (mechanical) | CV | < 4.1% | <4.1% |
| Thrombin time (mechanical) | CV | < 2.0% | <2.0% |
| AT III (chromogenic) | CV | < 2.9% | <2.9% |
| D-dimer (agglutination) | CV | < 13.3% | <13.3% |
| Precision Studies - Total Coefficient of Variation | Typically <15% (application dependent) | ||
| PT (optical) | CV | < 3.8% | <3.8% |
| PT (mechanical) | CV | < 3.8% | <3.8% |
| APTT (optical) | CV | < 2.1% | <2.1% |
| APTT (mechanical) | CV | < 2.3% | <2.3% |
| Factor IX (optical) | CV | < 7.2% | <7.2% |
| Factor IX (mechanical) | CV | < 8.4% | <8.4% |
| Factor X (optical) | CV | < 5.9% | <5.9% |
| Factor X (mechanical) | CV | < 8.8% | <8.8% |
| Fibrinogen (optical) | CV | < 4.7% | <4.7% |
| Fibrinogen (mechanical) | CV | < 5.4% | <5.4% |
| Thrombin time (mechanical) | CV | < 3.6% | <3.6% |
| AT III (chromogenic) | CV | < 5.2% | <5.2% |
| D-dimer (agglutination) | CV | < 33.0% | <33.0% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each comparison study. The document mentions "comparison studies of assays" and "precision studies," implying that multiple samples were tested for each assay. However, the exact number of patient samples, replicates, or data points used to generate the regression statistics and CVs is not provided in this summary.
- Data Provenance: Not specified in the document. It does not mention the country of origin of the data, nor whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of device submission. For in-vitro diagnostic analyzers, "ground truth" for performance studies (like correlation and precision) is established by comparing the new device's results against a legally marketed predicate device (the AMAX 190™ Coagulation Analyzer) or by measuring variability using standardized control materials or patient samples. There are no human "experts" establishing image-based ground truth in the way described for AI/ML imaging devices.
4. Adjudication Method for the Test Set
- Not applicable. The "adjudication method" (e.g., 2+1, 3+1) is relevant for studies involving human interpretation and consensus for ground truth, typically in imaging or clinical evaluation. For an in-vitro diagnostic analyzer, results are quantitative measurements, and "adjudication" in this sense does not occur. The comparison is statistical between two instruments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are used for evaluating diagnostic performance of AI-assisted human readers, typically in imaging. This document describes an automated coagulation analyzer, which does not involve human readers interpreting images assisted by AI. It's a standalone instrument.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this study represents a standalone performance evaluation for an automated instrument. The AMAX Destiny™ Coagulation Analyzer itself is the "algorithm only" device in this context (though it's a physical instrument, not just software). Its performance is evaluated independently by comparing its results directly with a predicate device and by assessing its precision. There is no human-in-the-loop for the device's operational output.
7. The type of ground truth used
- For this device, the "ground truth" (or reference standard) is implicitly the performance of the predicate device, the AMAX 190™ Coagulation Analyzer. In comparison studies, the predicate device serves as the reference against which the new device's performance is measured to demonstrate substantial equivalence. For precision studies, it's the expected variability around the measured values of control materials or patient samples. It's not "expert consensus," "pathology," or "outcomes data" in the typical sense for AI/ML imaging.
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm that is "trained" on data. It is a traditional automated laboratory instrument. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
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510(k) NOTIFICATION
Sigma Diagnostics Inc. March 13, 2002
| 510(k) Summary of Safety and Effectiveness | K021162 | |
|---|---|---|
| Submitted by: | Sigma Diagnostics545 South Ewing AvSt. Louis, MO 63103 | AUG 3 0 2002 |
| Contact Person: | William R. Gilbert, Ph.D.Manager, Scientific Affairs314-286-6693 | |
| 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 |
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Sigma Diagnostics Inc. March 13, 2002
The following coefficients of variation were obtained from precision studies:
| Within Run | Total | |
|---|---|---|
| PT (optical) | <2.0% | <3.8% |
| PT (mechanical) | <1.2% | <3.8% |
| APTT (optical) | <1.4% | <2.1% |
| APTT (mechanical) | <1.3% | <2.3% |
| Factor IX (optical) | <4.4% | <7.2% |
| Factor IX (mechanical) | <4.3% | <8.4% |
| Factor X (optical) | <3.0% | <5.9% |
| Factor X (mechanical) | <4.7% | <8.8% |
| Fibrinogen (optical) | <2.3% | <4.7% |
| Fibrinogen (mechanical) | <4.1% | <5.4% |
| Thrombin time (mechanical) | <2.0% | <3.6% |
| AT III (chromogenic) | <2.9% | <5.2% |
| D-dimer (agglutination) | <13.3% | <33.0% |
The safety and effectiveness of the AMAX Destiny™ Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics 545 South Ewing Avenue St. Louis, Missouri 63103
AUG 3 0 2002
Re: K021162
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 _________________________________________________________________________________________________________________________________________________________
§ 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.