(93 days)
Not Found
No
The device description and performance studies focus on a qualitative immunochromatographic assay read by a reflectance reader. There is no mention of AI or ML in the text.
No.
The device is for the detection of Zika virus IgM antibodies, which is a diagnostic purpose, not a therapeutic purpose. Therapeutic devices are used for treatment or prevention of disease.
Yes
The device is intended for the presumptive qualitative detection of Zika virus IgM antibodies, which is a diagnostic purpose to identify current or recent infection.
No
The device description explicitly states that the system is composed of a single-use immunochromatographic test and the DPP Micro Reader, which is a reflectance reader. This indicates the presence of physical 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 system is for the "presumptive qualitative detection of Zika virus IgM antibodies in human serum... plasma... whole blood specimens". This clearly indicates that the device is intended to be used in vitro (outside the body) to examine human specimens for diagnostic purposes.
- Device Description: The "Device Description" further clarifies that it's a "qualitative immunochromatographic assay for the presumptive detection of IgM antibodies to Zika virus". This describes a laboratory test performed on biological samples.
- Performance Studies: The detailed descriptions of clinical studies and analytical performance studies involving human specimens (serum, plasma, whole blood) and comparisons to predicate/reference devices are characteristic of the validation required for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (DEN180069) and name (InBios ZIKV Detect™ 2.0 IgM Capture ELISA) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
N/A
Intended Use / Indications for Use
DPP Zika IgM System
The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 4 but before day 8 and results are negative, testing must be repeated one week later. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of infection and may be detectable near day 4 post-onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post-onset of symptoms or after the window of detectable IgM closes and therefore do not preclude the possibility of Zika virus infection, past or present.
The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors.
The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader.
DPP Zika IgM System Control Pack
The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader.
DPP Micro Reader
The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Zika IgM System. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation; the results of DPP Zika IgM System cartridges must be read exclusively with the DPP Micro Reader.
Product codes (comma separated list FDA assigned to the subject device)
QFO, QCH, JJQ
Device Description
Chembio' s DPP Zika IgM System is a qualitative immunochromatographic assay for the presumptive detection of IgM antibodies to Zika virus. The DPP Zika IgM System is composed of:
-
A single-use immunochromatographic test for the presumptive detection of ZIK V 1. IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.
-
- The DPP Micro Reader to minimize errors from direct visual interpretation.
Materials provided
Each kit contains the reagents and tools to perform 20 tests:
20 individually pouched DPP Zika IgM Test Devices, each containing:
- 1 DPP Zika Test Device (membrane strip with immobilized recombinant Zika NS-● 1 antigen in the TEST (T) area and Protein A in the CONTROL (C) area.
- 1 Desiccant Pouch ●
20 Disposable 10 uL Microsafe Tubes
20 Sample vials
20 Transfer Pipets (100 µl)
- 1 DPP Zika IgM Buffer- YELLOW Cap
- 7.5 mL contains sodium phosphate, sodium chloride, EDTA, NP-40, Tween 20, ● Urea, chicken serum, gentamicin, streptomycin, and sodium azide as preservative.
- 1 Product Insert for the DPP Zika IgM System
1 Quick Reference Guide for the DPP Zika IgM System
Materials required but not provided (system related)
- Chembio DPP Micro Reader. ● Each kit contains:
- DPP Micro Reader with Zika IgM RFID sticker
- o 3 Lithium-ion, type CR2032 (3 V/230 mAh), coin cell batteries (installed)
- Custom power adapter cable (USB to 2.0 mm jack) -
- Power plug adaptor -
- DPP Cartridge Holder -
- Microfiber cloth -
- -User Manual
- DPP Micro Reader with Zika IgM RFID sticker
Additional required materials (assay related)
- Chembio DPP Zika IgM System Control Pack (Catalog #62-1001-1) ●
- 1 DPP Zika Reactive Control (300 µl): undiluted, naturally occurring Zika IgM positive plasma samples.
- 1 DPP Zika Non-Reactive Control (300 µ1): undiluted, naturally occurring Zika -IgM negative plasma samples.
- 1 DPP Zika Diluent (300 µl): undiluted, naturally occurring Zika IgM negative plasma samples.
- 1 Product Insert -
All reagents are supplied ready to use.
-
Clock, watch, or other timing device ●
-
Pipettor capable of delivering 10-100 µL of sample may be used in lieu of the ● disposable 10 uL MicroSafe Tube and 100 uL Transfer Pipets supplied with the Kit (for serum, potassium-EDTA plasma, and potassium-EDTA venous whole blood specimens or with the Chembio DPP Zika IgM System Control Pack)
-
Microcentrifuge Tubes
-
Disposable gloves
-
Antiseptic wipes ●
-
Biohazard disposal container
-
For fingerstick whole blood specimens:
- Sterile gauze
- Sterile Safety Lancets for fingerstick whole blood specimens
- For venous whole blood or serum/plasma specimens:
- Collection devices
For a fingerstick whole blood sample, sample collection uses a 10 ul Microsafe Tube. For human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood specimens, 10 ul of sample is collected using a calibrated laboratory pipet. Once the sample and buffer combination are added to the DPP Zika IgM Test Device, results are read by using the Chembio DPP Micro Reader, a portable, maintenance-free, battery-powered instrument that is operated by a single, multi-function button. The results of the DPP Zika IgM Test Device are presented through a 14-segment liquid crystal display (LCD) on the top of the DPP Micro Reader. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation, therefore the results must not be visually interpreted by the operator. Controls are kit lot specific and must not be interchanged between different DPP Zika IgM System lots.
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)
a. Clinical Studies
Positive Predictive Agreement
Positive Percent Agreement (PPA) was estimated for serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens by comparison with either the EUA or the FDA-cleared comparator assay.
Serum
Positive percent agreement for serum samples was evaluated using the following samples collected from patients residing in flavivirus areas:
-
. 99 serum samples collected from symptomatic individuals living in Peru, collected within 5-7 days after the onset of symptoms. All samples tested positive by a RT-PCR assay for Zika virus. Only 98 were tested in the EUA comparator assay due to a volume shortage in one sample.
-
. 11 serum samples sera from individuals living in the Dominican Republic, 6 being Zika-positive by a RT-PCR assay.
-
32 serum samples collected from 26 individuals during a time of arbovirus . outbreaks in a flavivirus endemic region of Brazil. All 26 individuals tested positive by a RT-PCR assay for Zika virus. The samples collected from individuals living in Brazil consisted of an initial serum specimen collected from 26 individuals on 1 to 17 days following the onset of fever symptoms, and a second serum specimen collected from 6 of these individuals after 6 to 9 days following the initial blood collection, for a total of 32 specimens.
For samples 'expected' to be positive, forty-one (41) samples were positive by the comparator assay. Overall PPA for serum samples with the EUA comparator assay was 95.1% (39/41; 95% CI=83.9-98.7%). A high percentage of false positive results was observed against the comparator, largely contributed to by the source of the samples.
Potassium-EDTA Plasma
Positive percent agreement for potassium-EDTA plasma was evaluated using archived samples consisting of eight serial samples collected from 50 symptomatic subjects confirmed positive for Zika virus by nucleic acid testing from the Dominican Republic. Of these, 299 IgM antibody samples from 48 individuals tested positive by the comparator. Samples included 12 pregnant women. Testing was performed at the manufacturer's laboratory. The results from this study demonstrate 100% positive agreement between the DPP Zika IgM Assay and the comparator for Zika IgM-positive potassium-EDTA plasma samples.
Positive percent agreement was also evaluated at external sites using 171 comparator positive IgM antibody potassium-EDTA plasma specimens from 39 individuals living in the Dominican Republic. Forty-nine (49) potassium-EDTA plasma samples prospectively collected from asymptomatic pregnant woman living in the continental United States that were found to be negative in the cleared comparator assay were interspersed for blinding. The 220 samples were divided and sent to two external clinical sites.
Potassium-EDTA Venous Whole Blood
The PPA of the DPP Zika IgM System for potassium-EDTA venous whole blood was evaluated by two studies. For the first study, samples were tested at either an internal site or at external sites:
- Samples tested at the internal site: ●
- 41 plasma samples prepared from a plasma replacement study with o serial bleeds over days from symptom onset from 6 individuals residing in the Dominican Republic. All donors were confirmed positive for Zika virus antibodies by the comparator assay.
- Frozen natural potassium-EDTA venous whole blood samples from ten o (10) antibody positive individuals from the Dominican Republic by the comparator assay.
- Samples tested at external sites: ●
- 171 antibody positive plasma specimens from a plasma replacement O study using the same subset described above for potassium-EDTA plasma plus the 49 antibody negative potassium-EDTA plasma specimens from asymptomatic pregnant women from the US as described above. Results were confirmed by the comparator assay.
The second study was conducted at 3 clinics in the US using prospectively-collected potassium-EDTA venous whole blood from subjects enrolled in an "all comers" fashion. One of the 300 subjects was excluded because their naïve whole blood tested reactive in the DPP Zika IgM System without being spiked, leaving 299 subjects for analysis. In order to assess positive agreement, samples were contrived by potassium-EDTA plasma replacement into venous whole blood samples to yield negative, low positive, and moderate positive specimens. The contrived samples were tested in a blinded fashion across three sites. Results were compared against the expected results based on the spiking level for each sample.
Fingerstick Whole Blood
The performance of the DPP Zika IgM System for fingerstick whole blood was evaluated at 4 near-patient sites in the US. A total of 375 adult subjects across the four sites were enrolled on an "all comers" basis. Fresh seronegative fingerstick whole blood samples (non-anticoagulated) were collected using sample vials that were pre-spiked with Zika IgM antibody positive plasma or potassium-EDTA plasma to create negative, low positive and moderate positive Zika samples. Presence or absence of Zika IgM antibodies in the spiking material was corroborated by comparator testing. Of the 375 subjects, two (2) were eliminated due to protocol deviations in data transcription and one (1) subject was excluded because their naïve whole blood tested reactive in the DPP Zika IgM System without being spiked, leaving 372 subjects for analysis. The vials were coded so that study staff and the two trained operators at the clinical laboratory were not aware of the predetermined reactivity of the spiked sample vials.
Negative Predicative Agreement
Negative Percent Agreement of the DPP Zika IgM System was established using prospectively collected potassium-EDTA venous and fingerstick whole blood samples from 250 subjects living in a Zika endemic area and 250 subjects living in a Zika nonendemic area. Potassium-EDTA venous samples and fingerstick whole blood were tested at seven (7) point-of-care sites including four (4) sites in areas endemic for mosquito-borne flaviviruses and three (3) sites in non-endemic areas.
Paired serum and potassium-EDTA plasma were forwarded to a reference laboratory where they were tested for Zika virus antibodies with the DPP Zika IgM System and the comparator method. Samples were expected to be negative for Zika IgM antibodies due to the low prevalence of Zika virus during the study. For those samples found positive, results were expressed as a percentage of positive results in the total population under study. Samples were tested using the DPP Zika IgM System, the cleared comparator assay, and an additional serology EUA test.
Non-Endemic Area:
Calculated using the score method.
Performance Against the FDA Plasma Zika Panel
Performance of the DPP Zika IgM System was evaluated by testing a panel of samples provided to the sponsor by FDA. The panel consists of plasma samples from individuals infected with Zika, West Nile, or Dengue viruses. Samples were collected at different time points from Zika infection documented by PCR; samples taken early or late after infection may be anticipated to be antibody negative. Samples were randomized and blinded for testing.
b. Analytical performance:
- Precision/Reproducibility of the DPP Zika IgM System: i.
DPP Zika IgM System reproducibility was evaluated at 3 different US sites with two runs per day, each run performed by one operator with one unique instrument (6 operators and 6 instruments in total) on 5 separate days. All samples were run as three replicates using three (3) lots of the DPP Zika IgM System. A blinded panel consisting of four plasma samples, including a 'negative', 'high negative', 'low positive,' and 'moderate positive,' were tested in this study.
Precision estimates were derived for reproducibility.
- Precision/Reproducibility of the DPP Zika IgM Control Kit ii.
Internal precision for the DPP Zika IgM Control Kit was tested at a single site over the course of 5 days by two different technicians using two instruments per operator. All samples were run in duplicate per run with 2 runs per day, morning and afternoon. One lot of the DPP Zika IgM System and one lot of the DPP Zika IgM Control Kit consisting of a DPP Zika Reactive Control, a DPP Zika Non-Reactive Control and a DPP Zika Diluent was used. The DPP Zika Reactive Control and DPP Zika Diluent was used in a ratio of 1:3 to make the low-reactive control as per the instructions for use fresh, each day of testing.
iii. Linearity/assay reportable range:
N/A
- Analytical specificity: iv.
a. Cross-Reactivity:
Cross-reactivity of the DPP Zika IgM System was evaluated by testing a total of 329 specimens from patients with IgM antibodies to closely related viruses as well as pathogens where infection produces symptoms similar to those observed during Zika virus infection, and autoantibodies which could potentially cause false positive results. A total of eighteen (18) different organisms/conditions per the supplier's Certificate of Analysis for various disease states, using FDA cleared/ approved devices when possible, were assessed. Of those, two (2) were found to be cross-reactive on the DPP Zika IgM System. The % Cross Reactivity for Cytomegalovirus and Dengue Virus on the DPP Zika IgM System is 5.3% and 2%, respectively. Babesia cross-reactivity was not evaluated.
b. Interference:
Potentially interfering endogenous substances were evaluated with the DPP Zika IgM System. Interfering substances were spiked into low reactive (n=3) and normal human plasma samples (n=3) to evaluate their impact on assay performance. Only one operator was involved in interpreting results in these studies. No interference was observed.
- Traceability, Stability, Expected values (controls, calibrators, or methods): V.
a. Traceability/Analytical Sensitivity:
The analytical sensitivity at the cut-off values for the DPP Zika IgM System was established using WHO 1st International standard for anti-Asian lineage Zika virus antibody (human) (NIBSC 16/352). This preparation contains antibodies reactive to Dengue virus. The standard was used to prepare a dilution series. The concentration of the reference reagent that corresponds to average reader values just above the cut-off of 20 (average values of
§ 866.3935 Zika virus serological reagents.
(a)
Identification. Zika virus serological reagents arein vitro diagnostic devices that consist of antigens or antibodies for the detection of Zika virus or Zika antibodies in human specimens from individuals who have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The detection aids in the diagnosis of current or recent Zika virus infection or serological status. Negative results obtained with this test do not preclude the possibility of Zika virus infection, past or present. Positive results should be interpreted with consideration of other clinical information and laboratory findings and should not be used as the sole basis for treatment or other patient management decisions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The labeling required under § 809.10(b) of this chapter must include:
(i) An intended use with a detailed description of what the device detects (Zika IgM antibodies, other Zika antibodies, or Zika antigens), the type of results provided to the user, the specimen type for which testing is indicated (
e.g., serum, whole blood), the clinical indications appropriate for test use, and the specific population(s) for which the test is intended.(ii) Performance characteristics from analytical and clinical studies required under paragraphs (b)(2)(ii) and (iii) of this section.
(iii) A detailed explanation of the interpretation of results and criteria for validity of results (
e.g., criteria that internal or external quality controls must meet in order for a test/test run to be valid, minimum signal strength that the sample has to yield to be interpretable as a valid result).(iv) Limiting statements indicating that:
(A) Results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. The test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence.
(B) Device results are intended to be followed up according to the latest professional guidelines (
e.g., recommendations from the Centers for Disease Control and Prevention) for the diagnosis of Zika virus infection.(C) Negative test results do not preclude the possibility of Zika virus infection, past or present.
(D) Specimens can result in false negative results on the device if collected outside of the appropriate response window for specific Zika virus antigens or antibodies, as determined by scientific evidence (
e.g., for IgM
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
June 3, 2020
Chembio Diagnostic Systems Louise Muscat Sigismondi R&D Director of Regulatory Affairs 3661 Horseblock Road Medford, New York 11763
Re: K200506
Trade/Device Name: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Regulation Number: 21 CFR 866.3935 Regulation Name: Zika Virus Serological Reagents Regulatory Class: Class II Product Code: QFO, QCH, JJQ Dated: February 27, 2020 Received: March 2, 2020
Dear Louise Sigismondi:
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,
Steven Gitterman, M.D., Ph.D. Deputy Director 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
2
Indications for Use
510(k) Number (if known) K200506
Device Name
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Indications for Use (Describe)
DPP Zika IgM System
The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 8 and results are negative, testing must be repeated one week later. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of infection and may be detectable near day 4 post-onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post-onset of symptoms or after the window of detectable IgM closes and therefore do not preclude the possibility of Zika virus infection, past or present.
The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors.
The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader.
DPP Zika IgM System Control Pack
The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader.
DPP Micro Reader
The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Zika IgM System. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation; the results of DPP Zika IgM System cartridges must be read exclusively with the DPP Micro Reader.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, connected to the word "CHEMBIO" in large, blue, sans-serif font. Below the word "CHEMBIO" is a blue line with small breaks in it, and below that is the text "DIAGNOSTIC SYSTEMS, INC." in a smaller, sans-serif font.
510(k) SUMMARY
Assigned 510(k) Number: K200506
| I. | Date Prepared: | June 1, 2020 |
|---|---|---|
| II. | Applicant Information: | Louise Sigismondi, Ph.D. |
| Research & Development Director of Regulatory Affairs | ||
| Chembio Diagnostic Systems Inc. | ||
| 3661 Horseblock Rd. | ||
| Medford, NY 11763 | ||
| Phone: 631-924-1135 | ||
| Fax: 631-924-2065 | ||
| Email: lsigismondi@chembio.com | ||
| III. | Regulatory Information: | |
| Trade Name: | DPP® Zika IgM System | |
| DPP® Zika IgM System Control Pack | ||
| DPP® Micro Reader | ||
| Common Name: | Zika virus assay | |
| Classification Names: | Zika Virus Serological Reagents: Class II, 21 CFR 866.3935; Microbiology (83) | |
| Assayed quality control material for clinical microbiology assays: Class II, 21CFR 866.3920; Microbiology (83) | ||
| Colorimeter, Photometer, Spectrophotometer for Clinical Use: Class I, 21 CFR §862.2300; Clinical Chemistry (75) | ||
| Product Code: | QFO - Zika Virus Serological Reagents | |
| QCH - Assayed quality control material for clinical microbiology assays | ||
| JJQ - Colorimeter, Photometer, Spectrophotometer for Clinical Use | ||
| IV. | Predicate Device: | InBios ZIKV Detect™ 2.0 IgM Capture ELISA |
| (DEN180069) |
5
Image /page/5/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, followed by the word "CHEMBIO" in blue capital letters. Below the word "CHEMBIO" is a blue line with small squares. Below the line is the text "DIAGNOSTIC SYSTEMS, INC." in smaller blue capital letters.
V. Intended use/Indication for use:
DPP Zika IgM System
The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 4 but before day 8 and results are negative, testing must be repeated one week later. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of infection and may be detectable near day 4 post-onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post-onset of symptoms or after the window of detectable IgM closes and therefore do not preclude the possibility of Zika virus infection, past or present.
The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors.
The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader.
DPP Zika IgM System Control Pack
The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader.
VI. Device Description:
Chembio' s DPP Zika IgM System is a qualitative immunochromatographic assay for the presumptive detection of IgM antibodies to Zika virus. The DPP Zika IgM System is composed of:
- A single-use immunochromatographic test for the presumptive detection of ZIK V 1. IgM antibodies in human serum (plain or separation gel), potassium-EDTA
6
Image /page/6/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, connected to the word "CHEMBIO" in blue capital letters. Below the word is a blue line with small dashes, and below that is the text "DIAGNOSTIC SYSTEMS, INC." in smaller blue capital letters.
plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.
-
- The DPP Micro Reader to minimize errors from direct visual interpretation.
Materials provided
Each kit contains the reagents and tools to perform 20 tests:
20 individually pouched DPP Zika IgM Test Devices, each containing:
- 1 DPP Zika Test Device (membrane strip with immobilized recombinant Zika NS-● 1 antigen in the TEST (T) area and Protein A in the CONTROL (C) area.
- 1 Desiccant Pouch ●
20 Disposable 10 uL Microsafe Tubes
20 Sample vials
20 Transfer Pipets (100 µl)
- 1 DPP Zika IgM Buffer- YELLOW Cap
- 7.5 mL contains sodium phosphate, sodium chloride, EDTA, NP-40, Tween 20, ● Urea, chicken serum, gentamicin, streptomycin, and sodium azide as preservative.
- 1 Product Insert for the DPP Zika IgM System
1 Quick Reference Guide for the DPP Zika IgM System
Materials required but not provided (system related)
- Chembio DPP Micro Reader. ● Each kit contains:
- DPP Micro Reader with Zika IgM RFID sticker
- o 3 Lithium-ion, type CR2032 (3 V/230 mAh), coin cell batteries (installed)
- Custom power adapter cable (USB to 2.0 mm jack) -
- Power plug adaptor -
- DPP Cartridge Holder -
- Microfiber cloth -
- -User Manual
- DPP Micro Reader with Zika IgM RFID sticker
Additional required materials (assay related)
- Chembio DPP Zika IgM System Control Pack (Catalog #62-1001-1) ●
- 1 DPP Zika Reactive Control (300 µl): undiluted, naturally occurring Zika IgM positive plasma samples.
- 1 DPP Zika Non-Reactive Control (300 µ1): undiluted, naturally occurring Zika -IgM negative plasma samples.
- 1 DPP Zika Diluent (300 µl): undiluted, naturally occurring Zika IgM negative plasma samples.
- 1 Product Insert -
All reagents are supplied ready to use.
- Clock, watch, or other timing device ●
- Pipettor capable of delivering 10-100 µL of sample may be used in lieu of the ● disposable 10 uL MicroSafe Tube and 100 uL Transfer Pipets supplied with the Kit (for serum, potassium-EDTA plasma, and potassium-EDTA venous whole blood specimens or with the Chembio DPP Zika IgM System Control Pack)
7
Image /page/7/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, followed by the word "CHEMBIO" in large, blue letters. Below the word "CHEMBIO" is the phrase "DIAGNOSTIC SYSTEMS, INC." in smaller, blue letters.
●
- Microcentrifuge Tubes
- Disposable gloves
- Antiseptic wipes ●
- Biohazard disposal container
- For fingerstick whole blood specimens:
- Sterile gauze
- Sterile Safety Lancets for fingerstick whole blood specimens
- For venous whole blood or serum/plasma specimens:
- Collection devices
For a fingerstick whole blood sample, sample collection uses a 10 ul Microsafe Tube. For human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood specimens, 10 ul of sample is collected using a calibrated laboratory pipet. Once the sample and buffer combination are added to the DPP Zika IgM Test Device, results are read by using the Chembio DPP Micro Reader, a portable, maintenance-free, batterypowered instrument that is operated by a single, multi-function button. The results of the DPP Zika IgM Test Device are presented through a 14-segment liquid crystal display (LCD) on the top of the DPP Micro Reader. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation, therefore the results must not be visually interpreted by the operator. Controls are kit lot specific and must not be interchanged between different DPP Zika IgM System lots.
VII. Purpose for Submission:
The purpose of this premarket notification is to submit a new device (DPP Zika IgM System) to FDA for consideration for clearance as a 510(k).
VIII. Comparison with predicate:
A comparison of the similarities and differences between the DPP Zika IgM System and the predicate is provided in the table below:
| Item | DPP Zika IgM System
(K200506) | ZIKV DetectTM 2.0 IgM Capture ELISA
(DEN 180069) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Analyte | Human IgM antibodies | Human IgM antibodies |
| Intended Use | The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a | The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of |
8
Image /page/8/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, followed by the company name in blue, capitalized letters. Underneath the company name, the words "DIAGNOSTIC SYSTEMS, INC." are written in smaller, blue, capitalized letters.
| | geographic region with active Zika transmission at
the time of travel, or other epidemiological criteria
for which Zika virus testing may be indicated).
Specimens from symptomatic patients or returning
travelers from endemic areas should not be
collected prior to 8 days after symptom onset or
after potential exposure as a sample collected
earlier may return a negative result. If testing is
needed after day 4 but before day 8 and results are
negative, testing must be repeated one week later.
Positive results must be confirmed by following
the latest CDC guidelines for the diagnosis of Zika
virus infection.
Results of this test are intended to be used in
conjunction with clinical observations, patient
history, epidemiological information, and other
laboratory results. Zika IgM levels over the
course of illness are not well characterized. Zika
IgM levels are variable during the course of
infection and may be detectable near day 4 post-
onset of symptoms and persist up to
approximately 12 weeks following initial
infection.
Negative results may be seen in specimens
collected before day four post-onset of symptoms
or after the window of detectable IgM closes and
therefore do not preclude the possibility of Zika
virus infection, past or present.
The Chembio DPP Zika IgM System is not
indicated for testing blood or plasma donors.
The test cannot be visually interpreted by the
operator and must be read on the DPP Micro
Reader. | travel, or other epidemiological criteria for
which Zika virus testing may be indicated).
Assay results are for the presumptive
detection of IgM antibodies to Zika virus
(ZIKV). Positive results must be confirmed
by following the latest CDC guidelines for
the diagnosis of Zika virus infection.
Results of this test are intended to be used in
conjunction with clinical observations,
patient history, epidemiological information,
and other laboratory evidence to make
patient management decisions. Zika IgM
levels are variable over the course of the
infection, and may be detectable near day
four post onset of symptoms and persist up
to approximately 12 weeks following initial
infection.
Negative results may be seen in specimens
collected before day four post onset of
symptoms or after the window of detectable
IgM closes, and therefore do not preclude the
possibility of Zika virus infection, past or
present.
This assay is not indicated for testing blood
or plasma donors. | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Differences | | | | |
| Sample Type | Human serum (plain or separation gel), potassium-
EDTA plasma, potassium-EDTA venous whole
blood, or fingerstick whole blood specimens | Human serum | | |
| Sample Size | Minimum of 10 µL before dilution | Minimum of 4 µL before dilution | | |
| Antibody
Target | NS-1 protein | Zika envelope glycoproteins | | |
| Type of Test | Lateral cross-flow dual path platform (DPP)
immunochromatographic assay | IgM Capture enzyme-linked immunosorbent
assay (ELISA) | | |
| External
Quality Control | Provided Separately | Included | | |
| Interpretation of
Results | Qualitative analysis by instrument: reactive or
non-reactive for Zika IgM antibodies; invalid | Qualitative analysis by instrument
Presumptive Zika Positive, Presumptive
Other Flavivirus Positive (non-Zika);
negative | | |
9
Image /page/9/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, followed by the word "CHEMBIO" in blue capital letters. Below the wordmark is the text "DIAGNOSTIC SYSTEMS, INC." also in blue capital letters. The logo is clean and professional, conveying a sense of global reach and expertise in diagnostic systems.
| | Interpretation of Results is performed by the DPP
Microreader. No calculations are required by the
user. | Interpretation requires calculations
performed by the user prior to reporting the
result |
|--------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Time to Result | Time to result is 15 minutes after addition of
Buffer into Well#2. | Time to result is approximately 3.5 hrs. |
| Reagent
Storage | 2-8°C Refrigerator or up to 23°C | 2-8°C Refrigerator only |
IX. Performance Standard:
| Standard | Title |
|---|---|
| CLSI EP05-A3 | Evaluation of Precision Performance of Quantitative Measurement Methods; Approved |
| Guideline | |
| CLSI EP07-3rd Ed. | Interference Testing in Clinical Chemistry; Approved Guideline—Third Edition |
| CLSI EP12-A2 | User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline, Second |
| Edition | |
| CLSI EP15-A3 | User of Performance for Precision and Trueness, Approved Guideline—Third Edition |
| CLSI EP17-A2 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved |
| Guideline - Second Edition | |
| CLSI EP25-A | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |
| CLSI EP37 | Supplemental Tables For Interference Testing In Clinical Chemistry |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential |
| performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| 21CFR 820 | Quality System Regulation |
| 21CFR 809.10 | Labeling for in vitro diagnostic products |
| 21 CFR §866.3935 | Special controls, Zika virus serological reagents |
| 21 CFR §862.2300 | Colorimeter, photometer, or spectrophotometer for clinical use |
X. Performance Characteristics:
a. Clinical Studies
Positive Predictive Agreement
Positive Percent Agreement (PPA) was estimated for serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens by comparison with either the EUA or the FDA-cleared comparator assay.
Serum
Positive percent agreement for serum samples was evaluated using the following samples collected from patients residing in flavivirus areas:
- . 99 serum samples collected from symptomatic individuals living in Peru, collected within 5-7 days after the onset of symptoms. All samples tested positive by a RT-PCR assay for Zika virus. Only 98 were tested in the EUA comparator assay due to a volume shortage in one sample.
10
Image /page/10/Picture/0 description: The image is the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, followed by the word "CHEMBIO" in blue, capitalized letters. Below the word "CHEMBIO" is a blue line with a small gap in the middle. Below the line is the text "DIAGNOSTIC SYSTEMS, INC." in smaller, blue, capitalized letters.
- . 11 serum samples sera from individuals living in the Dominican Republic, 6 being Zika-positive by a RT-PCR assay.
- 32 serum samples collected from 26 individuals during a time of arbovirus . outbreaks in a flavivirus endemic region of Brazil. All 26 individuals tested positive by a RT-PCR assay for Zika virus. The samples collected from individuals living in Brazil consisted of an initial serum specimen collected from 26 individuals on 1 to 17 days following the onset of fever symptoms, and a second serum specimen collected from 6 of these individuals after 6 to 9 days following the initial blood collection, for a total of 32 specimens.
For samples 'expected' to be positive, forty-one (41) samples were positive by the comparator assay. Overall PPA for serum samples with the EUA comparator assay was 95.1% (39/41; 95% CI=83.9-98.7%). A high percentage of false positive results was observed against the comparator, largely contributed to by the source of the samples.
| Overall Serum Agreement | |||||||
|---|---|---|---|---|---|---|---|
| Comparator1 | |||||||
| Zika IgM Reactive | Comparator1 | ||||||
| Zika IgM Non-Reactive | |||||||
| Collection | |||||||
| Site | Total | ||||||
| (n) | DPP Zika IgM | ||||||
| System | |||||||
| Reactive | |||||||
| (R)2 | DPP Zika IgM | ||||||
| System | |||||||
| Non- | |||||||
| Reactive | |||||||
| (NR)2 | Positive | ||||||
| Percent | |||||||
| Agreement | |||||||
| (95% CI) | DPP Zika IgM | ||||||
| System | |||||||
| Reactive | |||||||
| (R)2 | DPP Zika IgM | ||||||
| System | |||||||
| Non- | |||||||
| Reactive | |||||||
| (NR)2 | Negative | ||||||
| Percent | |||||||
| Agreement | |||||||
| Dominican | |||||||
| Republic | 11 | 8 | 23 | 80% | |||
| (8/10) | 14 | 0 | 0% | ||||
| (0/1) | |||||||
| Peru | 98 | 23 | 0 | 100% | |||
| (23/23)5 | 68 | 7 | 9.3% | ||||
| (7/755,6) | |||||||
| Brazil | 32 | 87 | 0 | 100% | |||
| (8/8) | 4 | 20 | 83.3% | ||||
| (20/24) | |||||||
| Total | 141 | 39 | 2 | 95.1% | |||
| (39/41)8 | |||||||
| (83.9-98.7%) | 73 | 27 | 27% | ||||
| (27/100) |
Overall Serum Agreement
1 EUA comparator assay reactive samples include Possible and Presumptive Zika Positive Specimens. EUA comparator assay non-reactive samples include Negative and Presumptive Other Flavivirus Positive specimens.
2This study was performed with an older version of the DPP Zika IgM System that was determined equivalent to the one under clearance.
3Negative for Zika IgM antibody by both the DPP Zika IgM System and a second authorized Zika IgM assay, while positive by an EUA Zika virus rtPCR assay and the EUA test used as a comparator.
"Negative for Zika IgM antibody by both the EUA test used as a comparator and a second authorized Zika IgM assay, while positive by an EUA Zika virus rtPCR assay.
5 All samples tested positive by a rtPCR assay for Zika virus.
6 All samples were 1 Plasma replacement is used here to describe a procedure by which venous whole blood was centrifuged, the plasma portion was removed and the pellet carefully suspended in an equal volume of plasma from another source positive for Zika antibodies.
13
Image /page/13/Picture/0 description: The image shows the logo for Chembio Diagnostic Systems, Inc. The logo features a blue globe on the left, followed by the word "CHEMBIO" in large, blue letters. Below the word "CHEMBIO" is a blue line with small squares. Below the line is the text "DIAGNOSTIC SYSTEMS, INC." in smaller, blue letters.
| Comparator1 | Comparator | ||
|---|---|---|---|
| Days Post | |||
| onset of | |||
| Symptoms | Zika IgM Reactive | Zika IgM Non-Reactive | |
| Positive | |||
| Percent | |||
| Agreement | 95% | ||
| Confidence | |||
| Interval | Negative Percent | ||
| Agreement | |||
| Negative2 | 0% | ||
| (0/1) | N/A | 98% | |
| (483/49) | |||
| 0-7* | 83.3% | ||
| (10/12) | 55.2-95.3% | NT | |
| 8-14 | 97.1% | ||
| (334/34) | 85.1-99.5% | NT | |
| 15-28 | 94.7% | ||
| (54/57) | 85.6-98.2% | NT | |
| 29-42 | 96.4% | ||
| (53/55) | 87.7-99.0% | NT | |
| 43-56 | 84.2% | ||
| (32/38) | 69.6-92.6% | NT | |
| 57-70 | 80.0% | ||
| 12/15 | 54.8-93.0% | 0% | |
| (0/1)1,5 | |||
| 71-84 | 90.9% | ||
| (10/11) | 62.3-93.4% | NT | |
| Total | 96.0% | ||
| (48/50) | |||
| Total | |||
| 8-84 | 92.4% | ||
| (194/210) | 88-95.3% |
Potassium-EDTA Venous Whole Blood Agreement Across Internal and Clinical Sites
1 EUA comparator assay reactive samples include Possible and Presumptive Zika Positive Specimens. 2 Cleared comparator assay non-reactive samples include Negative and Presumptive Other Flavivirus Positive (non-Zika) specimens.
3 For one sample, the microreader value indicated a negative result, but the end-user recorded an interpretation of "R" for Reactive.
4 For one sample, the microreader value indicated a reactive result, but the end-user recorded an interpretation of "NR" for Non-Reactive.
5 One sample was negative by 2nd authorized Zika IgM serology test.
- Data from Days 0 - 7 is not included in the calculation of total PPA because obtaining samples prior to 8 days after symptom onset or exposure is not recommended and false negative results are anticipated. NT: Not Tested, and not included in the calculations.
The second study was conducted at 3 clinics in the US using prospectively-collected potassium-EDTA venous whole blood from subjects enrolled in an "all comers" fashion. One of the 300 subjects was excluded because their naïve whole blood tested reactive in the DPP Zika IgM System without being spiked, leaving 299 subjects for analysis. In order to assess positive agreement, samples were contrived by potassium-EDTA plasma replacement into venous whole blood samples to yield negative, low positive, and moderate positive specimens. The contrived samples were tested in a blinded fashion across three
14
sites. Results were compared against the expected results based on the spiking level for each sample.
| Sample | Agreement | Score
95% CI | Combined Agreement |
|-----------------------------------------|--------------------|-----------------|---------------------------------------------|
| Negative | 100%
(120/120) | 96.9-100.0% | NPA
100% (120/120)
(95%CI 96.9-100%) |
| Low Reactive
(2.5x - DPP Zika
IgM
System³ | FDA
Cleared
Comparator¹ | Additional
EUA
Test² |
| Serum | 98.0%
(239/244)
95%CI
95.3-99.1 | 98.3%
(225/229)
95%CI
95.6-99.3 | 98.2%
(220/224)
95%CI
95.5-99.3 | 2.0%
(5ᵃ/250) | 2.4%
(6/250) | 8.4%
(21/250) |
| Potassium-EDTA
Plasma | 96.7%
(236/244)
95%CI
93.7-98.3 | 97.8%
(224/229)
95%CI
95.0-99.1 | 97.8%
(219/224)
95%CI
94.9-99.0 | 3.2%
(8ᵇ/250) | 2.4%
(6/250) | 8.4%
(21/250) |
| Potassium-EDTA
Venous Whole
Blood | 97.1%
(237/244)
95%CI
94.2-98.6 | 97.4%
(223/229)
95%CI
94.4-98.8 | 97.3%
(218/224)
95%CI
94.3-98.8 | 2.8%
(7ᶜ/250) | 2.4%
(6/250) | 8.4%
(21/250) |
| Capillary Whole
Blood | 98.4%
(239/243)⁴
95%CI
95.9-99.4% | 98.7%
(226/229)
95%CI
96.2-99.6 | 98.7%
(221/224)
95%CI
96.1-99.5 | 1.6%
(4ᵈ/250) | 2.4%
(6/250) | 8.4%
(21/250) |
Calculated using the score method.
1 Detects IgM antibodies against envelope
² Detects IgM and IgG antibodies anti NS-1
3 Detects IgM antibodies anti NS-1
4 FS result from one subject excluded due to protocol deviation (Test read