(82 days)
N/A De Novo
Not Found
No
The device description details a traditional immunochromatographic assay that relies on visual interpretation of colored lines, not computational analysis or learning algorithms. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an in vitro diagnostic immunoassay intended for the qualitative detection of Plasmodium antigens to aid in the diagnosis of malaria. It does not provide treatment or therapy.
Yes
The device is an in vitro immunochromatographic assay intended to aid in the rapid diagnosis of human malaria infections and differentiate Plasmodium falciparum infections. Its primary function is to detect specific antigens circulating in blood, which directly contributes to identifying a disease state.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, antibodies, reagents, and a book-shaped hinged device. It is a hardware-based in vitro diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood". This clearly indicates the device is used outside of the body to analyze biological samples.
- Device Description: The description details how the device works by analyzing whole blood specimens using antibodies immobilized on a membrane. This is a typical characteristic of an in vitro diagnostic test.
- Anatomical Site: The device analyzes "human venous and capillary EDTA whole blood", which is a biological sample taken from the body for analysis outside the body.
- Intended User / Care Setting: The intended user is "laboratories", which are settings where in vitro diagnostic tests are typically performed.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help diagnose diseases or conditions. The Binax NOW® Malaria Test fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Binax NOW® Malaria Test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a pan-malarial antigen, common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from other less virulent malarial infections. Negative results must be confirmed by thin / thick smear microscopy.
The Binax NOW® Malaria Test is for the laboratory diagnosis of malaria in individuals with signs and symptoms consistent with malaria infection.
Product codes (comma separated list FDA assigned to the subject device)
OAX
Device Description
In vitro immunochromatographic immunoassay
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
A blind study of the Binax NOW® Malaria Test was conducted at 3 separate sites using panels of blind coded specimens containing negative, limit of detection, and low positive P.f. and P.v. samples. Participants tested each sample multiple times on 3 different days.
The performance of the Binax NOW® test was compared to Giemsa malaria microscopy in a multi-center prospective study conducted in 2001 outside the U.S., in regions considered endemic for malaria. A total of 4,122 whole blood specimens collected from patients presenting with malaria-like symptoms were evaluated on the Binax NOW® test. Microscopy was considered positive only when asexual malaria forms were detected, since asexual forms (not gametocytes) are indicative of active infection.
The performance of the Binax NOW® test was compared to Giemsa malaria microscopy in a prospective study conducted in the eastern US in 2006-2007. One hundred (100) whole blood specimens collected from febrile patients were evaluated on the Binax NOW® test and on microscopy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
A blind study of the Binax NOW® Malaria Test was conducted at 3 separate sites using panels of blind coded specimens. There was 97% (140/144) agreement with expected test results, with no significant differences within run, between run, between sites, or between operators.
The Binax NOW® test clinical limit of detection (LOD) for P.f. was determined to be 1001-1500 parasites per ul and the clinical LOD for P.v. was determined to be 5001-5500 parasites per ul.
Analytic specificity was determined by testing 28 pathogenic microorganisms. All were negative.
Interference from Exogenous Blood Components: The following substances were evaluated and found not to affect test performance: Mefloquine, Doxycycline, Chloroquine, Hydroxychloroquine sulfate, Paludrine, Primaquine, Quinine, Sulfadoxine and Pyrimethamine, Amoxicillin, Cephalexin, Ciprofloxacin, Erythromycin, Aspirin, Acetaminophen, Ibuprofen.
Interference from Endogenous Blood Components: EDTA whole blood samples containing hemoglobin, protein, bilirubin (conjugated and unconjugated) or triglycerides at concentrations above physiological levels were tested. None affected test performance.
Interference from Unrelated Medical Conditions: Of 116 specimens, only 5 produced a false positive result (4 from subjects positive for rheumatoid factor, 1 from a subject with positive HAMA titer).
Clinical studies:
Clinical Sample Performance – Binax NOW® Malaria Test Sensitivity & Specificity - Endemic Population:
Multi-center prospective study in 2001 outside the U.S. (malaria endemic regions).
Sample size: 4,122 whole blood specimens from patients with malaria-like symptoms.
Comparison: Giemsa malaria microscopy.
Results:
Detection of P.f. Infection: Overall sensitivity 95.3% (531/557). Specificity 94.2% (3297/3500). Sensitivity varied by parasitemia level, from 99.7% (>5000 parasitemia) to 53.9% (0-100 parasitemia).
Detection of P.v. Infection: Overall sensitivity 68.9% (818/1187). Specificity 99.8% (2863/2870). Sensitivity varied by parasitemia level, from 93.5% (>5000 parasitemia) to 6.2% (0-100 parasitemia).
Detection of P.m. and P.o. Infection: Sensitivity 43.8% (7/16) for P.m. and 50% (1/2) for P.o.
Detection of Mixed P.f./P.v. Infection: Sensitivity 94.1% (32/34).
No differences were observed based on patient age or gender.
Clinical specificity:
Prospective study in the eastern US in 2006-2007.
Sample size: 100 whole blood specimens from febrile patients. All were negative for malaria by microscopy.
Results: 99 of 100 samples generated negative Binax NOW® test results, yielding a specificity of 99% (99/100).
Specificity vs. Microscopy: P.f. 100% (100 negatives out of 100), P.v., P.o., P.m. 99% (99 negatives out of 100 with 1 false positive).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
P.f. Detection:
Overall Sensitivity: 95.3% (531/557)
Specificity: 94.2% (3297/3500)
Sensitivity by Parasitemia Level:
5000: 99.7% (326/327)
1000 - 5000: 99.2% (126/127)
500 - 1000: 92.6% (25/27)
100 - 500: 89.2% (33/37)
0-100: 53.9% (21/39)
P.v. Detection:
Overall Sensitivity: 68.9% (818/1187) (Increases to 74.6% (886/1,187) if samples with two Binax NOW® test lines, microscopy positive for P.v. only, are included)
Specificity: 99.8% (2863/2870)
Sensitivity by Parasitemia Level:
5000: 93.5% (462/494)
1000 - 5000: 81.0% (277/342)
500 - 1000: 47.4% (37/78)
100 - 500: 23.6% (34/144)
0 - 100: 6.2% (8/129)
P.m. Detection:
Sensitivity: 43.8% (7/16) (Increases to 75.0% (12/16) if five P.m. microscopy positive samples with two test lines are included)
P.o. Detection:
Sensitivity: 50% (1/2)
Mixed P.f./P.v. Infection Detection:
Sensitivity: 94.1% (32/34)
Specificity in Low Incidence Population:
99% (99/100)
Specificity vs. Microscopy (Clinical Study):
P.f.: 100% (100 negatives out of 100)
P.v., P.o., P.m.: 99% (99 negatives out of 100)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
N/A De Novo
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3402 Plasmodium species antigen detection assays.
(a)
Identification. APlasmodium species antigen detection assay is a device that employs antibodies for the detection of specific malaria parasite antigens, including histidine-rich protein-2 (HRP2) specific antigens, and pan malarial antigens in human whole blood. These devices are used for testing specimens from individuals who have signs and symptoms consistent with malaria infection. The detection of these antigens aids in the clinical laboratory diagnosis of malaria caused by the four malaria species capable of infecting humans:Plasmodium falciparum ,Plasmodium vivax ,Plasmodium ovale , andPlasmodium malariae , and aids in the differential diagnosis ofPlasmodium falciparum infections from other less virulentPlasmodium species. The device is intended for use in conjunction with other clinical laboratory findings.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document:Plasmodium species Antigen Detection Assays.” See § 866.1(e) for the availability of this guidance document.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE
A. 510(k) Number: K061542
- B. Purpose for Submission: De Novo clearance
- C. Measurand: Plasmodium antigens
D. Type of Test: Qualitative, in vitro immunochromatographic assay E. Applicant:
Binax, Inc., d/b/a Inverness Medical Professional Diagnostics
- F. Proprietary and Established Names: Binax NOW® Malaria
G. Regulatory Information:
a) Regulation section: Plasmodium species antigen detection assay 21 CFR 866.3402. b) Classification: Class II Product Code: OAX c) Panel: 83 Microbiology
H. Intended Use:
- a) Intended use(s):
The Binax NOW® Malaria Test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a pan-malarial antigen, common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from other less virulent malarial infections. Negative results must be confirmed by thin / thick smear microscopy.
b) Indication(s) for use:
The Binax NOW® Malaria Test is for the laboratory diagnosis of malaria in individuals with signs and symptoms consistent with malaria infection.
- c) Special condition for use statement(s): The device is for prescription use only
1
- d) Special instrument Requirements: NA
- I. Device Description:
- In vitro immunochromatographic immunoassay
- J. Substantial Equivalence Information:
- N/A De Novo
K. Standard/Guidance Document Referenced (if applicable):
L. Test Principle:
The Binax NOW® Malaria Test is an immunochromatographic membrane assay that uses monoclonal antibodies to detect Plasmodium falciparum antigen and pan-malarial antigen (an antigen shared by all Plasmodium species causing human malaria) in venous and capillary whole blood specimens. These antibodies, and a control antibody, are immobilized on a membrane support as three distinct lines and are combined with a sample pad, which is impregnated with visualizing particles conjugated to control and anti-malaria antibodies, to create a test strip. This test strip is mounted in a book-shaped. hinged test device, along with wash and absorbent pads, intended to aid in the clearing of the membrane when the device is closed.
To perform the test, whole blood is applied to the sample pad. Malarial antigen present in the sample reacts to bind the anti-malaria conjugated antibody. Reagent A is added to the bottom of the test strip and allows the antigen-conjugate complexes to migrate along the test strip, where they are captured by the immobilized antibodies, forming the Test Line(s). Immobilized control antibody captures control conjugate, forming the Control Line. Once the blood sample has migrated the length of the test strip, the device is closed, allowing Reagent A that has been added to the wash pad to clear the test strip of excess blood.
Test results are interpreted by the presence or absence of visually detectable pink-topurple colored lines. A positive test result, read in 15 minutes, will include the detection of both a Test Line (or Test Lines) and a Control Line. A negative test result, read in 15 minutes, will produce only a Control Line, indicating that malarial antigens were not detected in the sample. Failure of the Control Line to appear, whether the Test Line(s) is present or not, indicates an invalid result.
M. Performance Characteristics (if/when applicable):
Analytical performance:
a) Precision/Reproducibility:
A blind study of the Binax NOW® Malaria Test was conducted at 3 separate sites using panels of blind coded specimens containing negative, limit of detection, and low positive P.f. and P.v. samples. Participants tested each sample multiple times on 3 different days. There was 97% (140/144) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days), between sites (3 sites), or between
2
operators (6 operators). The overall percent detection of each sample type is summarized below.
| Sample Type | % Detection |
|---|---|
| P.f. Low Positive | 94% (17/18) |
| P.f. LOD | 97% (35/36) |
| P.v. Low Positive | 94% (17/18) |
| P.v. LOD | 100% (36/36) |
| Negative | 3% (1/36)* |
Overall Percent Detection of P.f. and P.v. Samples
- One operator called a negative sample a P.f. positive.
-
a. Linearity/assay reportable range:
NA -
Traceability, Stability, Expected values (controls, calibrators, or method): b. NA
-
c. Detection limit:
P.f. and P.v. Limits of Detection:
In the study described above. Binax NOW® test clinical limit of detection (LOD) for P.f., defined as the parasitemia level in infected blood that produces positive Binax NOW® test results approximately 95% of the time, was determined to be 1001-1500 parasites per ul and the clinical LOD for P.v. was determined to be 5001-5500 parasites per ul.
d. Analytical specificity:
To determine the analytical specificity of the Binax NOW® Malaria Test, 28 pathogenic microorganisms (7 bacteria, 5 protists and 16 viruses) that may be present in whole blood were tested. All were negative when tested at the concentrations listed below.
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| TYPE | PATHOGEN TESTED | CONCENTRATION
TESTED |
|----------|-------------------------------------------------|---------------------------|
| Bacteria | Borrelia burgdorferi
(N40 strain) | $2.3 x 10^6$ organisms/ml |
| | Leptospira interrogans
(icterohaemorrhagiae) | $1.0 x 10^7$ organisms/ml |
| | Leptospira biflexa
(andamana) | $1.0 x 10^7$ organisms/ml |
| | Treponema pallidum | $1.0 x 10^5$ organisms/ml |
| | Rickettsia conorii
(Malish 7) | $1.0 x 10^7$ organisms/ml |
| | Rickettsia typhi
(Wilmington) | $1.0 x 10^7$ organisms/ml |
| | Orientia tsutsugamushi -
Rickettsia (Karp) | $1.0 x 10^7$ organisms/ml |
| | Babesia microti
(RMNS strain) | $4.4 x 10^7$ parasites/ml |
| Protists | Trypanosoma cruzi
(Y strain) | $1.3 x 10^6$ parasites/ml |
| | Leishmania donovani | $1.0 x 10^6$ parasites/ml |
| | Leishmania infantum | $1.0 x 10^6$ parasites/ml |
| | Leishmania chagasi | $1.0 x 10^6$ parasites/ml |
| | Cytomegalovirus (CMV)
(AD169) | $1.2 x 10^5$ PFU/ml |
| | Epstein-Barr virus (EBV) | $1.1 x 10^4$ copies/ml |
| | Dengue virus - West Pac 74 | $1.2 x 10^5$ PFU/ml |
| | Dengue virus - S16803 | $3.9 x 10^4$ PFU/ml |
| | Dengue virus - CH53489 | $1.3 x 10^4$ PFU/ml |
| | Dengue virus - TVP360 | $1.4 x 10^5$ PFU/ml |
| | Yellow Fever virus | $7.9 x 10^6$ PFU/ml |
| Viruses | West Nile virus | $1.6 x 10^5$ PFU/ml |
| | Chikungunya virus | $4.0 x 10^5$ PFU/ml |
| | Ross-River virus | $1.0 x 10^6$ PFU/ml |
| | Influenza A - Bayern/7/95 | $2.5 x 10^7$ TCID50/ml |
| | Influenza B - Victoria/2/87 | $1.0 x 10^7$ TCID50/ml |
| | HIV-1 (Subtype B) | $1.4 x 10^5$ copies/ml |
| | Hepatitis B | $2.0 x 10^5$ IU/ml |
| | Hepatitis C | $1.9 x 10^5$ IU/ml |
| | Rubella virus | > $2.0 x 10^2$ TCID50/ml |
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Interference from Exogenous Blood Components:
The following substances that may be artificially introduced into whole blood were evaluated in the Binax NOW® Malaria Test at the concentrations listed and were found not to affect test performance. Note: The analytical effects of these drugs on the Binax NOW® test were studied by taking whole blood and spiking it with quantities at high therapeutic concentrations and then testing these samples.
| Substance Type | Substance | Concentration |
|---|---|---|
| Anti-malarial drugs | ||
| (prevention) | Mefloquine (Lariam®) | 1 mg/ml |
| Doxycycline* (Vibramycin®) | 1 mg/ml | |
| Chloroquine | 1 mg/ml | |
| Hydroxychloroquine sulfate | 1 mg/ml | |
| Paludrine (Proguanil®) | 1 mg/ml | |
| Primaquine | 1 mg/ml | |
| Quinine | 1 mg/ml | |
| Sulfadoxine and | ||
| Pyrimethamine (Fansidar®) | 1 mg/ml | |
| Antibiotic | ||
| (treatment) | Amoxicillin (Trimox®) | 0.1 mg/ml |
| Cephalexin | 0.1 mg/ml | |
| Ciprofloxacin | 0.1 mg/ml | |
| Erythromycin | 0.1 mg/ml | |
| Anti-Inflammatory | ||
| Drugs | ||
| (treatment) | Aspirin | 1 mg/ml |
| Acetaminophen | 1 mg/ml | |
| Ibuprofen (NSAID) | 1 mg/ml |
- Doxcycline is also used as an antibiotic, typically at a lower dose than that tested in this study.
Interference from Endogenous Blood Components:
The Binax NOW® Malaria test was evaluated for possible interference from high levels of endogenous blood components, based on guidelines described in CLSI EP7. EDTA whole blood samples were tested that contained hemoglobin, protein, bilirubin (conjugated and unconjugated) or triglycerides at concentrations above physiological levels. None of the endogenous blood components affected test performance.
Interference from Unrelated Medical Conditions:
To assess the impact of unrelated medical conditions on the specificity of the Binax NOW® Malaria Test, 116 specimens from subjects with a variety of medical conditions unrelated to malaria were tested. Only five (5) of the 116 specimens tested produced a false positive result on the Binax NOW® Test, four (4) from subjects known to be positive for rheumatoid factor and one (1) from a subject with a positive human antimouse antibody (HAMA) titer.
Comparison studies:
a. Method comparison with predicate device:
N/A
- b. Matrix comparison:
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Clinical studies:
a. Clinical sensitivity: Clinical Sample Performance – Binax NOW® Malaria Test Sensitivity & Specificity - Endemic Population:
The performance of the Binax NOW® test was compared to Giemsa malaria microscopy in a multi-center prospective study conducted in 2001 outside the U.S., in regions considered endemic for malaria. A total of 4,122 whole blood specimens collected from patients presenting with malaria-like symptoms were evaluated on the Binax NOW® test. Microscopy was considered positive only when asexual malaria forms were detected, since asexual forms (not gametocytes) are indicative of active infection.
Forty-four percent (1.796/4.122) of the tested population was microscopy positive for malaria, including 557 patients with P.f., 1,187 with P.v., 16 with P.m., 2 with P.o., and 34 with mixed P.f./P.v. infections. Fifty-nine percent of patients were male, 41% female, 19% pediatric ( 5000 | 99.7% (326 /
327) | 98 - 100% |
| 1000 -
5000 | 99.2% (126 /
127) | 96 - 100% |
| 500 -
1000 | 92.6% (25 / 27) | 76 - 99% |
| 100 - 500 | 89.2% (33 / 37) | 75 - 97% |
| 0-100 | 53.9% (21 / 39) | 37 - 70% |
| Overall | 95.3% (531 /
557) | 93 - 97% |
Binax NOW® Malaria Test Sensitivity and Specificity for P.f. vs. Microscopy
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| SPECIFICITY FOR P.f. | |
|---|---|
| % Specificity | 95% CI |
| 94.2% (3297 / 3500) | 93-95% |
Detection of P.v. Infection
Binax NOW® test sensitivity and specificity for detection of P.v. vs. microscopy is presented below. Sensitivity was evaluated based on the levels of parasitemia (parasites per ul) observed in microscopy. There were 68 samples generating two Binax NOW® test lines that were microscopy positive for P.v. only. When these samples are included in the true positive calculation, Binax NOW® test sensitivity for overall detection of P.v. increases from 68.9% to 74.6% (886/1,187).
Binax NOW® Malaria Test Sensitivity and Specificity for P.v. vs. Microscopy
| SENSITIVITY FOR P.v. | ||
|---|---|---|
| Parasitem | ||
| ia Level | % Sensitivity | 95%CI |
| > 5000 | 93.5% (462 / 494) | 91 - |
| 96% | ||
| 1000 - | ||
| 5000 | 81.0% (277 / 342) | 76 - |
| 85% | ||
| 500 - | ||
| 1000 | 47.4% (37 / 78) | 36 - |
| 59% | ||
| 100 - 500 | 23.6% (34 / 144) | 17 - |
| 31% | ||
| 0 - 100 | 6.2% (8 / 129) | 3 - |
| 12% | ||
| Overall | 68.9% (818 / 1187) | 66 - |
| 72% |
| SPECIFICITY FOR P.v. | ||||
|---|---|---|---|---|
| % Specificity | તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | |||
| CI | ||||
| 99.8% (2863 / | 99- | |||
| 2870) | 100% |
Detection of P.m. and P.o. Infection
Binax NOW® test sensitivity was 43.8% (7/16) for detection of P.m. and 50% (1/2) for detection of P.o. When five P.m. microscopy positive samples that generated two test
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lines in the Binax NOW® test are included in the true positive calculation, Binax NOW® test sensitivity for P.m. increases from 43.8% to 75.0% (12/16).
Detection of Mixed P.f./P.v. Infection
Thirty four samples were both P.f. and P.v. positive by microscopy, based on the detection of asexual forms of both species. The Binax NOW® test detected 32 of these samples by generating both test lines, for a sensitivity of 94.1% (95% CI of 81-98%).
b. Clinical specificity:
The performance of the Binax NOW® test was compared to Giemsa malaria microscopy in a prospective study conducted in the eastern US in 2006-2007. One hundred (100) whole blood specimens collected from febrile patients were evaluated on the Binax NOW® test and on microscopy. All 100 samples were negative for malaria on microscopy, and 99 of these samples generated negative Binax NOW® test results, yielding a specificity of 99% (99/100) in this low incidence population. Binax NOW® test specificity versus microscopy is presented below.
Binax NOW® Malaria Test Specificity vs. Microscopy
| - / - | + / - | % Spec | 95% CI | |
|---|---|---|---|---|
| P.f. | 100 | 0 | 100% | 96-100% |
| P.v., P.o., P.m. | 99 | 1 | 99% | 95-100% |
N. Proposed labeling:
The labeling is sufficient and it satisfies the requirement of 21 CFR Part 809.10.
WARNING
This test should only be used by laboratories that have or can acquire blood samples containing Plasmodium falciparum for use as a positive control. It is recommended that the level of the positive control used challenge the assay cutoff.
Clinical performance has not been adequately established for P. ovale (P.o.) and P. malariae (P.m.). The user must establish performance characteristics of this test with these Plasmodium species.
The test is not intended for use in screening asymptomatic populations.
O. Conclusion:
The submitted material in this premarket notification is complete and supports a substantial equivalence decision.