(184 days)
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No
The document describes an automated system for in vitro coagulation studies and provides performance metrics based on correlation and precision, which are standard for laboratory analyzers and do not indicate the use of AI/ML. There are no mentions of AI, ML, image processing, or training/test sets typically associated with AI/ML development.
No
The device is described as a system for "in-vitro coagulation studies," meaning it analyzes samples outside of a living organism for diagnostic purposes, not for treating a condition.
Yes
The device is used for "in-vitro coagulation studies," and the summary of performance studies mentions "patient specimens over the normal, diagnostic and therapeutic range," indicating its use in diagnosing and monitoring patient conditions related to coagulation.
No
The device description explicitly states it is an "Automated system for in vitro coagulation studies," which implies a physical hardware component for performing the tests, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the Coag-A-Mate MTX is for "performing in-vitro coagulation studies". The term "in-vitro" means "in glass" or "in the lab," referring to tests performed on samples taken from the body, which is the core definition of an IVD.
- Device Description: The description further clarifies it as an "Automated system for in vitro coagulation studies".
- Performance Studies: The description of performance studies involving "patient specimens" and "analyte" further supports its use in testing biological samples.
Therefore, based on the provided information, the Coag-A-Mate MTX is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.
Product codes
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Device Description
Automated system for in vitro coagulation studies, clot based and chromogenic.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A comparison study was conducted using patient specimens over the normal, diagnostic and therapeutic range. R values ranged from (0,954 - 0.994) for clot based screening assays. (0.988 -0.995 for clot based quantitative assays and (r = 0.954) for chromogenic assays. Total imprecision for each analyte was well within NCCLS recommendations. Precision studies were performed following NCCLS EPS-T2 "Evaluation of Precision Performance of Clinical Chemistry Devices." Total precision c.v.'s were less than 5% for clot based screening assays, less than 8% for clot based quantitative assays and less than 7% for colorimetric assays. Data was generated on the CAM MTX using commercially available normal and abnormal control plasma.
Key Metrics
Correlation coefficients ranged from r = 0.954 to 0.995 for clot based assays. A correlation coefficient of r = 0.954 was obtained for assays requiring spectrophotometric measurement at a specified wavelength such as chromogenic assays. Total precision c.v.'s were less than 5% for clot based screening assays, less than 8% for clot based quantitative assays and less than 7% for colorimetric assays.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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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5.0 510(k) Summary
JAN 22 1997
Coag-A-Mate MTX
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.
(A)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
Submitter's Name: Organon Teknika Corporation
Submitter's Address: 100 Akzo Avenue, Durham, NC, 27712
Submitter's Telephone: (919) 620-2634
Submitter's Contact: Ann M. Quinn
Date 510(k) Summary Prepared: July 19, 1996
(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.
Trade or Proprietary Name: Coag-A-Mate MTX
Common or Usual Name: Multipurpose System for In Vitro Coagulation Studies
Classification Name: Multipurpose System for In Vitro Coagulation Studies
- (2)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence.
Device Equivalent to: Organon Teknika MDA-180 (K924453) Organon Teknika Coag-A-Mate X2 (K813564)
(2)(4) A description of the device
.
Device description: Automated system for in vitro coagulation studies, clot based and chromogenic.
(೩)(೭) A statement of the intended use of the device
Device Intended Use: The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.
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A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.
The CAM MTX, MDA-180 and CAM-X2 are multipurpose systems capable of performing invitro coagulation studies, all three perform clot based assays. The MDA-180 and CAM MTX are also capable of performing chromogenic assays.
Similar to the MDA-180, the Coag-A-Mate MTX is a fully automated system that has features which increase its ease of use. Table 1.1 below outlines similarities/differences between the MDA-180 and the CAM MTX.
| Table 1.1 | |||
|---|---|---|---|
| Similarities and Differences Between the MDA-180 and the CAM-MTX |
| MDA-180 | CAM-MTX | |
|---|---|---|
| Spectrophotometric Detection | 405 - 710 nm | 405 nm |
| Random Access | yes | - |
| Stat Mode Capability | yes | yes |
| LIS Interface | yes | yes |
| Assay Capability | Clot Based | |
| Chromogenic | ||
| Immunoassay | Clot Based | |
| Chromogenic | ||
| Ancillary Components | Imidazole Buffer | |
| Reagent Water | ||
| Wash Solution | ||
| Probe Cleaner | ||
| VeriCal Calibrators | ||
| Test Cuvettes | Probe Cleaner | |
| Cleaning Solution | ||
| Test Cuvettes | ||
| User Definable Assay | ||
| Parameters | yes | yes |
(b)(1) A brief discussion of the nonclinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.
Testing was performed to determine normal range, correlation and bias, precision and interfering substances. Interfering substances, and specimen collection and preparation are well documented for these types assays and are in accordance with NCCLS standards and recommendations of the International Society of Thrombosis and Hemostasis.
(b)(2) A brief discussion of the clinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.
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A comparison study was conducted using patient specimens over the normal, diagnostic and therapeutic range. R values ranged from (0,954 - 0.994) for clot based screening assays. (0.988 -0.995 for clot based quantitative assays and (r = 0.954) for chromogenic assays. Total imprecision for each analyte was well within NCCLS recommendations.
(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).
The performance characteristics of the new device are comparable to those of the predicate device and typical of these systems in general. The data presented in the premarket notification demonstrate that the new device performs substantially equivalent to the predicate device. Comparison studies were performed to demonstrate the CAM MTX is equivalent to the MDA-180 and CAM-X2 for the performance of in vitro congulation studies (clotting, chromogenic).
Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering the normal, therapeutic and diagnostic range. Correlation coefficients ranged from r = 0.954 to 0.995 for clot based assays. A correlation coefficient of r = 0.954 was obtained for assays requiring spectrophotometric measurement at a specified wavelength such as chromogenic assays.
Precision studies were performed following NCCLS EPS-T2 "Evaluation of Precision Performance of Clinical Chemistry Devices." Total precision c.v.'s were less than 5% for clot based screening assays, less than 8% for clot based quantitative assays and less than 7% for colorimetric assays. Data was generated on the CAM MTX using commercially available normal and abnormal control plasma.
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