(602 days)
No
The description focuses on electrical impedance measurement and data collection software, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) device used to measure platelet aggregation for the qualitative assessment of platelet function. It is intended for diagnostic purposes and not for treating patients.
Yes
The device "measure[s] platelet aggregation... for the qualitative assessment of platelet function", which is used in "professional laboratory use" and evaluated clinical "sensitivity and specificity" against "Platelet Function Status" based on a "physician panel's review of each patient's clinical history". These details indicate its use in diagnosing health conditions related to platelet function.
No
The device description explicitly states that the Multiplate 5.0 is an instrument that measures platelet function using electrical impedance and employs multiple electrodes in a disposable test cell. It also includes an integrated computer system, screen, keyboard, mouse, and electronic pipette, indicating significant hardware components beyond just software.
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 Multiplate 5.0 aggregometer and the associated reagents (ADPtest and ASPItest) are "intended for in vitro use".
- Purpose: The device measures platelet aggregation in whole blood samples to assess platelet function. This is a diagnostic test performed on a biological sample outside of the body.
- Reagents: The reagents are also described as being for "in vitro diagnostic use".
- Professional Laboratory Use: The intended user is a "professional laboratory", which is typical for IVD devices.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Multiplate 5.0 aggregometer is intended for in vitro use to measure platelet aggregation in response to Arachidonic acid or ADP in citrated whole blood samples for the qualitative assessment of platelet function.
The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
Product codes
JOZ
Device Description
The Multiplate® 5.0 measures platelet function in whole blood samples using electrical impedance. The Multiplate technology employs multiple electrodes in a disposable test cell. Four electrodes form two independent sensor units allowing for two measurements on the same sample. Five independent channels of the instrument allow for testing of multiple reagents or samples simultaneously.
The instrument provides a five channel aggregometer and an integrated computer system with associated software and is connected to a computer screen, keyboard, mouse, and an electronic pipette. The software is used for data collection and is not used for diagnosis or treatment.
Currently, two test reagents (ADP and Arachidonic acid) are available that activate platelets through specific platelet membrane receptor/signal transduction pathways in order to measure platelet function or alterations in function.
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
For professional laboratory use only.
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
Multi-center studies were run to compare the performance of the Multiplate 5.0 to the predicate device. Samples from 171 patients suspected of decreased platelet function were drawn and measured in duplicate.
Clinical sensitivity and specificity were calculated against Platelet Function Status. Platelet Function Status of each sample was based upon a physician panel's review of each patient's clinical history. Samples from 91 patients suspected of decreased platelet function which were drawn and measured in duplicate.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two multi-center studies were performed.
The first study compared the performance of the Multiplate 5.0 to the predicate device.
Sample size: 171 patients.
Key results: The positive and negative percent agreements (PPA and NPA) of the Multiplate to the Chrono-log were calculated.
For Arachidonic acid: PPA = 100% [96%, 100% CI], NPA = 65% [54%, 75% CI].
For ADP: PPA = 93% [81%, 97% CI], NPA = 54% [45%, 62% CI].
The second study analyzed sensitivity and specificity.
Sample size: 91 patients.
Key results: Clinical sensitivity and specificity were calculated against Platelet Function Status, which was based on a physician panel's review of each patient's clinical history.
For ASPItest (Arachidonic acid): Sensitivity = 93% [85%, 97% CI], Specificity = 67% [44%, 84% CI].
For ADPtest: Sensitivity = 59% [46%, 70% CI], Specificity = 80% [63%, 90% CI].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Arachidonic acid (against predicate): Positive Percent Agreement (PPA) = 100%, Negative Percent Agreement (NPA) = 65%
ADP (against predicate): Positive Percent Agreement (PPA) = 93%, Negative Percent Agreement (NPA) = 54%
ASPItest (clinical): Sensitivity = 93%, Specificity = 67%
ADPtest (clinical): Sensitivity = 59%, Specificity = 80%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).
0
JUL 27 2012 K1035
Multiplate 5.0: 510(k) Summary Version: 1.0 / Date: 26.07.2012 Released by: Verum Diagnostica GmbH
Image /page/0/Picture/2 description: The image shows the Multiplate logo. The logo consists of a circular graphic on the left and the word "multiplate" on the right. The graphic is a black circle with white lines inside, resembling a fingerprint or a stylized mountain range. The word "multiplate" is written in a bold, sans-serif font, with a small circle containing a dot above and to the right of the "e".
| Device: | Multiplate Analyzer 5.0 |
|---|---|
| Prepared on: | November 29, 2010 |
| Submitted by: | Verum Diagnostica GmbH, Reichenbachstrasse 27, 80469 Munich, Germany |
| Contact person: | Dr. Maximilian Zucker, +49 89 12 55 56-0 |
| Device Names: | - Trade name: Multiplate 5.0 |
- Common name: Whole Blood Analyzer
- Classification name: Automated Platelet Aggregation System |
The Multiplate 5.0 has been found to be substantially equivalent to the previously cleared Chronolog Model 700 Whole Blood Lumi-Aggregometer (K050265).
1. Device Description
The Multiplate® 5.0 measures platelet function in whole blood samples using electrical impedance. The Multiplate technology employs multiple electrodes in a disposable test cell. Four electrodes form two independent sensor units allowing for two measurements on the same sample. Five independent channels of the instrument allow for testing of multiple reagents or samples simultaneously.
The instrument provides a five channel aggregometer and an integrated computer system with associated software and is connected to a computer screen, keyboard, mouse, and an electronic pipette. The software is used for data collection and is not used for diagnosis or treatment.
Currently, two test reagents (ADP and Arachidonic acid) are available that activate platelets through specific platelet membrane receptor/signal transduction pathways in order to measure platelet function or alterations in function.
2. Intended Use
The Multiplate 5.0 aggregometer is intended for in vitro use to measure platelet aggregation in response to Arachidonic acid or ADP in citrated whole blood samples for the qualitative assessment of platelet function.
The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
3. Technical Description
The Multiplate uses the same scientific principles of detection as the predicate Chrono-log Model 700 with the exception that it does not include the capability of platelet function measurement based on luminescence or turbidimetric light transmission measurement.
1
Both devices employ the same principle of measurement: electrical impedance, first cited in 1980 by Cardinal and Flower, (J Pharmacol Methods.1980;3:135-158). An electrical current passes through individual sets of electrodes. When the electrodes come into contact with a whole blood sample platelets bind to and cover the electrodes in a small monolayer. As the platelets become activated after exposure to a specific platelet agonist, the platelets strongly adhere to the electrodes and begin to aggregate. An increase in the number of platelets adhering to the electrodes increases the resistance (impedance) between the pair of electrodes.
Potential improvements of the Multiplate system are the introduction of dual sensor technology that records two measurements in each test cell based on two individual pairs of electrodes. The mean value is then reported. The final measurement is reported in Units (U) which represents the area under the curve that is generated by graphing the change in resistance.
4. Performance
...
Multi-center studies were run to compare the performance of the Multiplate 5.0 to the predicate device. Samples from 171 patients suspected of decreased platelet function were drawn and measured in duplicate.
The positive and negative percent agreements of the Multiplate to the Chrono-log were calculated. The results were considered positive if the test value was below the reference range for the specific device. The results were considered negative if they fell within the reference range for the specific device. Using this data, the positive percent agreements (PPA) and negative percent agreements (NPA) were calculated.
| Arachidonic acid | ADP | |||
|---|---|---|---|---|
| PPA | NPA | PPA | NPA | |
| Agreement | 100% | 65% | 93% | 54% |
| 95% Confidence Interval | [96%, 100%] | [54%, 75%] | [81%, 97%] | [45%, 62%] |
Sensitivity and Specificity were analysed by considering samples from 91 patients suspected of decreased platelet function which were drawn and measured in duplicate. Clinical sensitivity and specificity were calculated against Platelet Function Status. Platelet Function Status of each sample was based upon a physician panel's review of each patient's clinical history.
| Sensitivity | Specificity | |
|---|---|---|
| ASPItest | 93% | 67% |
| 95% CI | [85%, 97%] | [44%, 84%] |
| ADPtest | 59% | 80% |
| 95% CI | [46%, 70%] | [63%, 90%] |
5. Conclusion
The data and information provided in this submission demonstrate substantial equivalence and support clearance of the 510(k) premarket notification for the Multiplate 5.0 and associated reagents.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
10903 New Hampshire Avenue Silver Spring, MD 20993
AUG = 7 2012
Verum Diagnostica GmbH c/o Maximilian Zucker, Ph.D. Reichenbachstrasse 27 80469 Munich Germany
Re: K103555
Trade/Device Name: Verum Multiplate 5.0 Regulation Number: 21 CFR 864.5700 Regulation Name: Automated Platelet Aggregation System Regulatory Class: Class II Product Code: JOZ Dated: June 19, 2012 Received: June 22, 2012
Dear Dr. Zucker:
This letter corrects our substantially equivalent letter of July 27, 2012.
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 (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 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.
3
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Reena Philip
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Multiplate 5.0 (Indications for Use of the ADPtest)
Indications For Use:
The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use . (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic | |
| Device Evaluation and Safety |
510(k) K103555
Page 1 of
5
Indications for Use
510(k) Number (if known): K103555
Device Name:
Multiplate 5.0 (Indications for Use of the ASPItest)
Indications For Use:
The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
S10K K103555
Page 1 of
6
Indications for Use
510(k) Number (if known):
Device Name: Multiplate 5.0 (Indications for Use of the Liquid Control Set)
Indications For Use:
For use as an assayed quality control verification of the resistance measure of impedance aggregometry.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
510k)
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of