(215 days)
Not Found
No
The summary describes a device that measures protein levels and uses computational integration to generate a score, but there is no mention of AI or ML algorithms being used in this process. The "computational integration" likely refers to standard calculations based on the measured protein levels.
No
The device is an in-vitro diagnostic test intended to aid in differentiating bacterial from viral infections. It does not provide treatment or directly affect the structure or function of the body.
Yes
The device is an immunoassay that measures specific proteins in serum samples to help differentiate bacterial from viral infections, which is a diagnostic purpose.
No
The device description explicitly states that the MeMed BV™ test consists of an automated analyzer with built-in hardware and software, and a disposable cartridge containing reagents and controls. This indicates the device includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Device Description" explicitly states: "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."
Furthermore, the "Intended Use / Indications for Use" describes the device as 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." This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, prevention, or treatment of a disease or condition.
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 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.
Product codes
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 chemiluminescencebased analyte measurements of patient serum 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 from patients with suspected acute bacterial or viral infection.
Health Care Providers requesting samples to be tested by clinical laboratory technicians
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
The diagnostic performance of the MeMed BV™ test was established by a prospective, multicenter, observational, blinded study.
Sample size: 1,016 infectious subjects (476 prospectively recruited adult and pediatric patients and 540 archived cases).
Data source: 11 medical centers (9 in the US and 2 in Israel).
Annotation protocol: Expert adjudication comparator method (forced diagnosis for indeterminate cases) with the experts blinded to C-reactive protein (CRP) and procalcitonin (PCT) values for the primary objective. Expert adjudication comparator method (indeterminate cases removed from analysis) with the experts given CRP and PCT values for the secondary objective.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical performance
- Limit of Quantitation (LoQ): Evaluated using two cartridge lots with one MeMed Key analyzer. Each sample was tested three times on three non-consecutive days. Results showed the test passes acceptance criteria for total error (TRAIL: TE
§ 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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September 1, 2021
MeMed Diagnostics Ltd. Efrat Hartog-David Director of Regulatory Affairs and Quality Assurance Nahum Heth 5 Tirat Carmel, 3508504 Israel
Re: K210254
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: January 29, 2021 Received: January 29, 2021
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.
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
1
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 (OS) 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 mediation-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,
Kristian Roth, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210254
Device Name MeMed BV™M
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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 Heth 5 Tirat Carmel, 3508504, Israel
Phone: +972-4-8500302 Contact Person: Efrat Hartog-David, Ph.D.
Date Prepared: January 29, 2021
Name of Device: MeMed BV™
Common or Usual Name: MeMed BV™
Classification Name: Immunoassay for host biomarkers of infection
Regulatory Class: Class II
Product Code: QPS
Predicate Devices
BioMerieux, Inc, VIDAS B.R.A.H.M.S. PCT (PCT) (K162827)
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 chemiluminescencebased analyte measurements of patient serum 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 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.
Comparison with Predicate Device
The MeMed BV is substantially equivalent to the predicate device the VIDAS B.R.A.H.M.S. PCT (PCT) (K162827). The MeMed BV has similar intended and indications for use, as
4
well as similar basic technological principles to the predicate device. The minor differences in technological characteristics 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 below.
Performance Data
-
- Analytical performance:
- 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 with one MeMed Key analyzer and the samples described in Table 1. Each sample was tested three times on three non-consecutive days.
| Analyte | Total Error Accuracy Goal |
|---|---|
| TRAIL | TE 400 mg/dL |
| Bilirubin (unconjugated) | >400 mg/dL |
| Caffeine | 216 mg/dL |
| Cetirizine HCL | 8.7 mg/dL |
| Dextramethorphan | 0.0312 mg/dL |
| Doxycycline | 36 mg/dL |
| HAMA (human α-mouse | |
| Ab) | 168 ng/mL |
640 (titer) | N/A | N/A | N/A |
| Hemoglobin | >10,000 mg/dL | Aqueous | 10% v/v | 10 mg/ mL, zero spike: 0.9%
NaCl |
| Heparin | 66,000 U/L | Aqueous | 5% v/v | 3300 U/L |
| Human serum Albumin
(HSA, total protein) | powder | Aqueous | 10% v/v | 60 mg/mL, in serum |
| Ibuprofen (Motrin) | 438 mg/dL | Ethanol | 5% v/v | 219 µg/mL |
| Levofloxacin | 72 mg/dL | HCl | 5% v/v | 36 µg/mL |
| Loratidine | 0.0174 mg/dL | Ethanol | 5% v/v | 87 ng/mL |
| Nicotine | 0.1983 mg/dL | Ethanol | 5% v/v | 969 ng/mL |
| Oxymetazoline HCl | 0.0012 µg/mL | Aqueous | 5% v/v | 0.0006 µg/mL |
| Phenylephrine | 0.06 mg/dL | Aqueous | 5% v/v | 30 ng/mL |
| Prednisolone | 0.198 mg/dL | Ethanol | 5% v/v | 1200 ng/mL |
| Rheumatoid Factor (RF) | 25 kU/L | Aqueous | 2% v/v | 500 IU/mL |
| Triglycerides/Triolein | >15,000 mg/dL | Sucrose and
NaCl | 10% v/v | 15 mg/mL, in Ethanol |
| Table 11. Panel of interferents for screening1 | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------------ |
- Concentrations based on recommended testing concentrations in CLSI EP7-A2 Interference testing in clinical chemistry and CLSI EP37 supplemental tables for interference testing in clinical chemistry)
| Cross-reactant | Stock | Reconstitution
volume | Reference
matrix | Volume
spiked | Final
Concentration
tested |
|----------------------------------------------------------------|-------|--------------------------|---------------------|------------------|----------------------------------|
| Recombinant Human 4-1BB
Ligand/TNFSF9 Protein | 25 µg | 250 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human CD40
Ligand/TNFSF5 (HEK293-
expressed) | 25 µg | 250 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
Lymphotoxin alpha1/beta2
Protein | 25 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
Lymphotoxin alpha2/beta1
Protein | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human TNF-
alpha Protein | 20 µg | 200 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
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| Cross-reactant | Stock | Reconstitution
volume | Reference
matrix | Volume
spiked | Final
Concentration
tested |
|--------------------------------------------------------------|----------------|--------------------------|---------------------|------------------|----------------------------------|
| Lymphotoxin-alpha/TNF-beta
Protein | | | | | |
| Recombinant Human
Adiponectin/Acrp30 Protein | 0.266
mg/mL | NA | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL13/BLC/BCA-1 Protein | 25 µg | 250 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL5/ENA-78 Protein | 25 µg | 250 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL6/GCP-2 Protein | 25 µg | 250 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL1/GRO alpha Protein | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL3/GRO gamma Protein | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human IFN-
gamma Protein | 100 µg | 500 µL | DDW | 5% v/v | 50 ng/mL |
| Recombinant Human IL-
8/CXCL8 Protein | 50 µg | 500 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL11/I-TAC Protein | 25 µg | 250 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL7/NAP-2 Protein | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
CXCL9/MIG Protein | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human/Rhesus
Macaque/Feline CXCL12/SDF-
1a | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human/Feline
CXCL12/SDF-1 beta aa 22-93 | 10 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
| Recombinant Human
Pentraxin 2/SAP Protein | 50 µg | 200 µL | DDW | 5% v/v | 50 ng/mL |
| Recombinant Human
Pentraxin 3/TSG-14 Protein | 50 µg | 100 µL | PBS | 5% v/v | 50 ng/mL |
The data shows that the 95% confidence interval for the bias lies within +/-12.5 score units for all the interferants and cross-reactants in the indicated concentrations for both bacterial and viral clinical samples. Thus, it can be concluded that there is no interference or cross-reactivity caused by the above mentioned compounds at the indicated concentrations.
h. Human Anti-Mouse Antibody (HAMA) Interference
Interference of human anti-mouse antibody (HAMA) was conducted by a dose-response experimental design consisting of 5 serum levels with different amounts of HAMA: Low Pool as described in Table 13 below. The Interference of HAMA was assessed by a comparison of TRAIL, CRP, and IP10 concentrations in the measured serum samples to their nominal concentration values.
Each sample was run on 2 MeMed Key Analyzers with a total of 8 repeats for each sample. The acceptance criterion was that TRAIL, CRP, and IP10 concentrations, when run on clinical serum sample mixed with HAMA positive sample, shall measure concentrations within +/- 10% compared to their nominal concentration. The interference of HAMA on analytes concentration was examined by two independent experiments using two different HAMA-positive samples.
13
| TRAIL | CRP | IP10 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Mean | ||||||||||||
| measur | |||||||||||||
| ed | Mean | ||||||||||||
| nomin | |||||||||||||
| al | Recov | ||||||||||||
| ery % | Pass | ||||||||||||
| /Fail | Mean | ||||||||||||
| measur | |||||||||||||
| ed | Mean | ||||||||||||
| nomin | |||||||||||||
| al | Recove | ||||||||||||
| ry % | Pass | ||||||||||||
| /Fail | Mean | ||||||||||||
| measur | |||||||||||||
| ed | Mean | ||||||||||||
| nomin | |||||||||||||
| al | Recove | ||||||||||||
| ry % | Pass | ||||||||||||
| /Fail | |||||||||||||
| Sample | |||||||||||||
| 1 | Level 1 | 132.3 | 109.5 | 1338.6 | |||||||||
| Level 2 | 103.8 | 107.0 | 97% | Pass | 78.1 | 84.7 | 92% | Pass | 991.8 | 1010.2 | 98% | Pass | |
| Level 3 | 81.7 | 84.0 | 97% | Pass | 59.8 | 55.3 | 108% | Pass | 681.7 | 756.8 | 90% | Pass | |
| Level 4 | 57.3 | 58.8 | 98% | Pass | 32.1 | 30.4 | 106% | Pass | 409.7 | 428.3 | 96% | Pass | |
| Level 5 | 35.8 | 1.0 | 175.0 | ||||||||||
| Sample | |||||||||||||
| 2 | Level 1 | 138.1 | 109.7 | 1293.6 | |||||||||
| Level 2 | 115.5 | 115.7 | 100% | Pass | 83.7 | 85.0 | 98% | Pass | 967.0 | 977.3 | 99% | Pass | |
| Level 3 | 93.4 | 100.2 | 93% | Pass | 60.4 | 55.6 | 109% | Pass | 661.1 | 697.3 | 95% | Pass | |
| Level 4 | 79.9 | 77.8 | 103% | Pass | 31.9 | 30.9 | 103% | Pass | 355.5 | 381.1 | 93% | Pass | |
| Level 5 | 62.3 | 1.5 | 101.1 |
Table 13. HAMA interference testing results
For both HAMA samples the recovery of TRAIL, IP-10 and CRP are within the +/- 10%. The results show that the three assays are tolerant to high HAMA concentrations.
i. In-Use Stability
An in-use stability study was conducted to demonstrate the allowable handling conditions from blood draw to serum sample input into the cartridge. Stability was assessed for each MeMed BV test measurand (TRAIL/IP-10/CRP) and the MeMed BV test resulting score for four patient serum panel members representing two samples with 'low' scores of approximately 5 and two samples with 'high' scores of approximately 95 as described in Table 14.
The study was performed in one laboratory on four days, one day per panel member. Three MeMed Key analyzers and one lot of cartridges were used. Calibration was performed at the beginning of the study using one lot of calibration reagents.
| Panel member | Sample type | Score | Number of patients |
|---|---|---|---|
| A1, A2 | Infectious serum specimen | High (score | |
| approximately 95) | 2 | ||
| B1, B2 | Infectious serum specimen | Low (score | |
| approximately 5) | 2 |
Table 14. Patient specimens (panel members)
For each panel member, the incubations listed Table 15 were performed with the package insert indicated SST tube before centrifugation and testing with the MeMed BV Test. There were three replicate runs for each time point performed in parallel on three MeMed Key analyzers.
| SST
| Tube # | Time at room temp before centrifugation (mins) |
|---|---|
| 1 | 30 (shortest time for coagulation according to the IFU of BD SST Vacutainer) |
| 2 | 60 |
| 3 | 90 |
Table 15. Incubation Time at Room Temperature
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| SST
| Tube # | Time at room temp before centrifugation (mins) |
|---|---|
| 4 | 120 |
| 5 | 150 |
The mean values, regression lines, confidence intervals and significance level of the difference of the slope from 0 were examined for each of the incubation times. The minimum acceptable incubation time was approximately 130 minutes and the incubation time before an observed failure was 120 minutes. Thus, the 120 minute time period at room temperature before centrifygation preparation for use in the MeMed BV test was established as 120 minutes.
j. Freeze-thaw stability
A study was conducted to validate stability between fresh and frozen specimens. This study examined the stability of the MeMed BV test result (score) using 40 paired fresh and frozen specimens as indicated in Table 16. The study was performed in one laboratory. Each sample was tested three times on the same MeMed Key analyzer using one lot of cartridges and one lot of calibrator reagents. Calibration was performed on the first day and repeated after two weeks.
| Score bin | Interpretation | # of specimen tested |
|---|---|---|
| $90 \le s \le 100$ | High likelihood of | |
| bacterial infection | 12 | |
| $65 |