(87 days)
No
The summary describes an automated immunoassay measuring specific protein levels and computationally integrating them to generate a numeric score. While it involves computational integration, there is no mention of AI, ML, or related terms, nor is there a description of training or test sets for an AI/ML model. The performance studies focus on analytical and clinical validation of the immunoassay and score interpretation bins, not on the performance of an AI/ML algorithm.
No
The device is an in-vitro diagnostic test intended to aid in the differentiation of bacterial from viral infections, not to treat or prevent a disease.
Yes
The device is described as an "In-Vitro-Diagnostic device" and its intended use is "as an aid to differentiate bacterial from viral infection," which are diagnostic purposes.
No
The device description explicitly states that the device consists of an "automated analyzer with built-in hardware and software" and a "disposable cartridge that contains the reagents and controls." This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device..."
- Intended Use: The "Intended Use / Indications for Use" describes the device as measuring proteins in patient samples (serum and whole blood) to aid in differentiating bacterial from viral infection. This is a classic example of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide diagnostic information.
- Device Description: The description of the device as an automated immunoassay that measures analytes in patient samples using reagents and controls further confirms its nature as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatic serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.
Product codes (comma separated list FDA assigned to the subject device)
QPS
Device Description
The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.
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
adult and pediatric
Intended User / Care Setting
patients presenting to the emergency department or urgent care center and with samples collected at hospital admission
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)
1. Analytical performance:
The analytical performance testing supports the two newly introduced elements, the performance of the MeMed BV® test (serum) with the introduction of a new Master Calibration Curve (MCC) and the performance of the MeMed BV® test using venous WB specimen (also with the use of the new calibration scheme). For the first element (serum) only, the raw data that have been collected for previous analytical validation studies (K222332) were utilized for the re-calculation and re-analysis by applying the MCC.
-
a. Limit of Quantitation: The study used two cartridge lots (per each test script; serum and whole blood) with one MeMed Key® analyzer. Each sample was tested three times on three non-consecutive days.
- Serum script test: For the defined LLOQ concentration level of TRAIL, CRP, and IP10 (X1.0., TRAIL 15 pg/mL, CRP 1 mg/L, IP10 100 pg/mL) the results achieved the following maximal TE values: TRAIL 21%, CRP 9%, and IP10 15%.
- WB script test: For the defined LLOQ concentration level of TRAIL, CRP, and IP10 (X1.0., TRAIL 15 pg/mL, CRP 1 mg/L, IP10 100 pg/mL) the results achieved the following maximal TE values: TRAIL 10%, CRP 10%, and IP10 14%.
-
b. Reproducibility/Precision:
- Serum samples: The study was performed in three laboratories. At each site, a single operator preformed tests on two different analyzers using one cartridge lot. Each panel member was run in triplicates on each analyzer, on each day, over 5 non-consecutive days. Calibration was performed on the first day on each analyzer; one calibrator lot was used. External controls were run daily using one lot of ECs. The reproducibility results complied with the pre-established acceptance criteria for score and individual analytes (CV ≤ 15 % for measurands, SD
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.
0
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June 30, 2023
MeMed Diagnostics Ltd. Efrat Hartog-David VP of Regulatory Affairs and Quality Assurance Nahum Het 7 Tirat Carmel, 3508506 Israel
Re: K230944
Trade/Device Name: MeMed BV Regulation Number: 21 CFR 866.3215 Regulation Name: Device To Detect And Measure Non-Microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis Regulatory Class: Class II Product Code: QPS Dated: April 4, 2023 Received: April 4, 2023
Dear Efrat Hartog-David:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Noel J. Gerald -S
Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
MeMed BV
Indications for Use (Describe)
The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatic serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Z Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
MeMed Diagnostics Ltd.'s MeMed BV®
Submitter
MeMed Diagnostics Ltd. Nahum Het 7 Tirat Carmel, 3508506, Israel Phone: +972-4-8500302 Facsimile: +972-4-8500298 Contact Person: Efrat Hartog-David, Ph.D, Olga Boico, Ph.D Date Prepared: April 4, 2023
Name of Device: MeMed BV®
Common or Usual Name: MeMed BV®
Classification Name: Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
Regulatory Class: Class II, 21 CFR 866.3215
Product Code: QPS
Predicate Devices
MeMed Diagnostics LTD., MeMed BV® (K222332)
Device Description
The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.
Intended Use / Indications for Use
The MeMed BV® test is an automated semi-quantitative immunoassay that measures three nonmicrobial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV® is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial
4
or viral infection, who have had symptoms for less than seven days. The MeMed BV® test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.
Comparison with Predicate Device
The MeMed BV® is substantially equivalent to the predicate device, MeMed Diagnostics LTD. MeMed BV® (K222332). The FDA cleared MeMed BV® device has similar intended use and indications for use, as well as the same basic technological principles to the predicate device. The described changes in the indications for use (venous whole blood sample type) and technological characteristics (calibration scheme) are supported by the performance testing and do not raise any new questions of safety and efficacy. A substantial equivalence table summarizing the similarities and differences between the MeMed BV® and its predicate device is provided in the table below (MeMed Diagnostics, Ltd.'s MeMed BV® Test Substantial Equivalence Chart).
| Intended Use /
Indications for
| Use | Proposed modified MeMed BV® Test | MeMed BV® Test (K222332) |
|---|---|---|
| The MeMed BV® test is an automated | ||
| semi-quantitative immunoassay that | ||
| measures three non-microbial (host) | ||
| proteins (TRAIL, IP-10, and CRP) in adult | ||
| and pediatric serum and venous whole | ||
| blood samples and is intended for use in | ||
| conjunction with clinical assessments and | ||
| other laboratory findings as an aid to | ||
| differentiate bacterial from viral infection. | ||
| MeMed BV® is indicated for use in | ||
| patients presenting to the emergency | ||
| department or urgent care center and | ||
| with samples collected at hospital | ||
| admission from patients with suspected | ||
| acute bacterial or viral infection, who | ||
| have had symptoms for less than seven | ||
| days. The MeMed BV® test generates a | ||
| numeric score that falls within discrete | ||
| interpretation bins based on the | ||
| increasing likelihood of bacterial infection. | The MeMed BV® test is an automated semi- | |
| quantitative immunoassay that measures | ||
| three non-microbial (host) proteins | ||
| (TRAIL, IP-10, and CRP) in adult and | ||
| pediatric serum samples and is intended for | ||
| use in conjunction with clinical assessments | ||
| and other laboratory findings as an aid to | ||
| differentiate bacterial from viral infection. | ||
| MeMed BV® is indicated for use in | ||
| patients presenting to the emergency | ||
| department or urgent care center and with | ||
| samples collected at hospital admission | ||
| from patients with suspected acute bacterial | ||
| or viral infection, who have had symptoms for | ||
| less than seven days. The MeMed | ||
| BV® test generates a numeric score that falls | ||
| within discrete interpretation bins based on | ||
| the increasing likelihood of bacterial infection. | ||
| User Population | Same | Health Care Providers requesting samples to |
| be tested by clinical laboratory technicians | ||
| Specimen | Human serum or Venus whole blood | Human serum |
| Assay Principle | Same | Sandwich immunoassay technology |
| Analytes of | ||
| Interest | Same | TRAIL, IP-10, and CRP |
| Assay | ||
| Technique | Same | Chemiluminescent immunoassay (CLIA) |
Table 1. MeMed Diagnostics, Ltd.'s MeMed BV Test Substantial Equivalence Chart
5
| Proposed modified MeMed BV® Test | MeMed BV® Test (K222332) | |
|---|---|---|
| Detection | ||
| Method | Same | Automated chemiluminescence-based |
| analyte measurement using MeMed Key® | ||
| Instrument | ||
| Assessment | ||
| Process | Same | Software algorithm-based |
| Test Result | ||
| Reporting | Same | Numerical values with risk bins |
| Time to Result | Same | Approximately 15 minutes |
| Calibration | ||
| Frequency | Same | Every Four weeks |
| Calibration | ||
| Scheme | Backwards compatibility with the legacy | |
| calibration scheme (for serum samples) | ||
| as well as a modified master calibration | ||
| curve scheme (MCC; upon calibration, | ||
| the factory-derived master curve is | ||
| adjusted) | Legacy calibration scheme | |
| Volume for | ||
| Sample | 150 µL for venous whole blood | |
| 100 µL for serum | 100 µL for serum |
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Performance Data
1. Analytical performance:
The analytical performance testing supports the two newly introduced elements, the performance of the MeMed BV® test (serum) with the introduction of a new Master Calibration Curve (MCC) and the performance of the MeMed BV® test using venous WB specimen (also with the use of the new calibration scheme). For the first element (serum) only, the raw data that have been collected for previous analytical validation studies (K222332) were utilized for the re-calculation and re-analysis by applying the MCC.
a. Limit of Quantitation
The Total Error and precision for the lowest concentration of each measurand that could be reliably measured (i.e., Limit of Quantification or LoQ) by the MeMed BV® Test was evaluated in accordance with CLSI EP17-A2、Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. The study used two cartridge lots (per each test script; serum and whole blood) with one MeMed Key® analyzer and the samples described below. Each sample was tested three times on three non-consecutive days.
| Analyte | Total Error Accuracy Goal |
|---|---|
| TRAIL | TE |