(31 days)
MDA® 180
Not Found
No
The document describes software updates focused on adding new methods, improving algorithms for error reduction, and enhancing waveform analysis, but does not mention AI or ML.
No
The device is described as a system for in vitro coagulation studies and clinical analyses related to hemostasis and thrombosis. It is an analytical tool, not a device used to provide therapy or treatment to a patient.
Yes
The device description states it "determines results or reaction rates" for "clinical analyses related to hemostasis and thrombosis", which are diagnostic activities. The intended use section also mentions "in vitro coagulation studies".
No
The device description clearly states it is a "fully automated, random access analyzer" and an "instrument" that "determines results or reaction rates by detecting changes in the light transmitted through a reaction mixture." This indicates the device includes significant hardware components (analyzer, instrument, optics, fluidics) in addition to the software. The 510(k) is for a software update to an existing hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the MDA is a "multipurpose system for in vitro coagulation studies." "In vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Device Description: The "Device Description" further clarifies that the system is used to "perform clinical analyses related to hemostasis and thrombosis." These are clinical tests performed on samples (like blood) taken from a patient to diagnose or monitor a medical condition.
- Assays Performed: The device is capable of running "various clot based, chromogenic and immunoassays." These are all types of laboratory tests commonly used for diagnostic purposes.
Therefore, based on the provided information, the MDA system is designed and intended for use in performing diagnostic tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MDA is a multipurpose system for in vitro coagulation studies and is capable of running various clot based, chromogenic and immunoassays.
Product codes
JPA
Device Description
The Multi-Channel Discrete Analyzer (MDA) system is a fully automated, random access analyzer used to perform clinical analyses related to hemostasis and thrombosis. The instrument determines results or reaction rates by detecting changes in the light transmitted through a reaction mixture. Flexibility in optics, fluidics, and software allow the MDA to perform many different assays including traditional clotting assays, chromogenic assays, and immunoassays.
The MDA B.30 software version Q08.00 is an update to the MDA B.23 software version Q05.00 and was developed with the same intended use.
The modifications to the MDA B.30 software consists of the following:
-
- add new methods in order to accommodate new OEM supplied chromogenic reagents:
- new endpoint algorithms to reduce the erroneous error rate 2. without increasing the erroneous result rate;
-
- new wash macro for Simplastin HTF to minimize precipitate build up in Probe D;
-
- add a new B4 latex method to allow customers to validate a Free Protein S assay;
-
- add Italian and Spanish languages; and
-
- new and enhanced waveform analysis features
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 data for the 12 representative assays were all well within the criteria stated. There was 100% agreement between the predicate software B.23 and new software version B.30 for all methods. MDA b.30 demonstrated its ability to determine correct clotting times for samples that had increased levels of interfering substances.
The erroneous result rate was much improved in B.30 when compared to B.23. The erroneous error rate was much improved in B.30 when compared to B.23.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MDA® 180:MDA® B.23
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Premarket Notification 510(k) bioMérieux, Inc. MDA® B.30
510(k) SUMMARY
(a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
bioMérieux, Inc. Submitter's Name: 100 Rodolphe Street Submitter's Address: Durham, North Carolina 27712 (919) 620-2968 Submitter's Telephone: Jocelyn Jennings, RAC Submitter's Contact: Associate Staff RA Specialist February 22, 2005 Date 510(k) Summary prepared:
- (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:
MDA® 180:MDA II (B.30 software)
Common or Usual Name:
Coagulation instrument
Classification Name:
21CFR864.5425 Multipurpose system for in vitro coagulation studies
(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence:
Device Equivalent to:
MDA® 180:MDA® B.23
- (a)(4) A description of the device
Device Description:
CONFIDENTIAL
1
The Multi-Channel Discrete Analyzer (MDA) system is a fully automated, random access analyzer used to perform clinical analyses related to hemostasis and thrombosis. The instrument determines results or reaction rates by detecting changes in the light transmitted through a reaction mixture. Flexibility in optics, fluidics, and software allow the MDA to perform many different assays including traditional clotting assays, chromogenic assays, and immunoassays.
The MDA B.30 software version Q08.00 is an update to the MDA B.23 software version Q05.00 and was developed with the same intended use.
The modifications to the MDA B.30 software consists of the following:
-
- add new methods in order to accommodate new OEM supplied chromogenic reagents:
- new endpoint algorithms to reduce the erroneous error rate 2. without increasing the erroneous result rate;
-
- new wash macro for Simplastin HTF to minimize precipitate build up in Probe D;
-
- add a new B4 latex method to allow customers to validate a Free Protein S assay;
-
- add Italian and Spanish languages; and
-
- new and enhanced waveform analysis features
(a)(5) A statement of the intended use of the device.
Device Intended Use:
The MDA is a multipurpose system for in vitro coagulation studies and is capable of running various clot based, chromogenic and immunoassays.
(a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device.
The data contained in this submission support the claim that the MDA B.30 software is substantially equivalent to the MDA B.23 software in terms of intended use, functional requirements and performance. The MDA instrument platform that contains B.23 software is the exact same instrument platform that contains B.30 software. The operating system, optics, sample type, reagent assays and target population are identical for both versions of software.
(b)(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the Premarket notification submission for a determination of substantial equivalency.
2
There were no nonclinical tests, referenced or relied on for this submission.
(b)(2) 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).
Precision data for the 12 representative assays were all well within the criteria stated. There was 100% agreement between the predicate software B.23 and new software version B.30 for all methods. MDA b.30 demonstrated its ability to determine correct clotting times for samples that had increased levels of interfering substances.
The erroneous result rate was much improved in B.30 when compared to B.23. The erroneous error rate was much improved in B.30 when compared to B.23.
3
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Re:
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Jocelyn Jennings, RAC Associate Staff Regulatory Affairs Specialist bioMerieux, Inc. 100 Rodolphe Street Durham, North Carolina 27712
K050513 Trade/Device Name: MDA® 180:MDA II (B.30 software) Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: February 25, 2005 Received: March 1, 2005
APR - 1 2005
Dear Ms. Jennings:
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 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 OFF Part 8017), systems (QS) regulation (QS) regulation (21 CFR Part 820). This letter requirements use in marketing your device as described in your Scction 510(k) premarket whitification. 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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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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may obtain other getain onal 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,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATIONS OF USE FORM
1050513 510(k) Number (if known):
Device Name: MDA®:MDA® II (B.30 software)
Indications For Use:
The MDA is a multipurpose system for in vitro coagulation studies and is capable of running various clot based, chromogenic and immunoassays.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyatuation (ODE)
(Per 21 CFR 801.109)
(ODE)
Division Sign-Off
Office of In Vitro Diag Evaluation and Sat
510(k) K050513
CONFIDENTIAL
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