(269 days)
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No
The device description details a standard ELISA assay process, which is a laboratory technique that does not inherently involve AI or ML. The performance studies and metrics are based on traditional statistical analysis of assay results. There is no mention of AI, DNN, or ML in the document.
No
This device is an in vitro diagnostic (IVD) test intended for the qualitative detection of IgM antibodies to West Nile virus, aiding in presumptive diagnosis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection."
No
The device description details a laboratory assay involving physical reagents, incubations, washing steps, and reading results on an ELISA reader, which is a hardware instrument. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "qualitative detection of IgM antibodies to West Nile virus in human serum and plasma". This clearly indicates it's used to test samples taken from the human body.
- Purpose: The test is intended as an "aid in the presumptive laboratory diagnosis of West Nile virus infection". This means it's used to help diagnose a disease.
- Method: The description details a laboratory procedure (ELISA) performed on patient samples.
- Device Description: The description outlines the components and steps of a laboratory test kit.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of human tissues with the tissues of another human being, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The EUROIMMUN Anti-West Nile Virus ELISA (IgM) is intended for the qualitative detection of IgM antibodies to West Nile virus in human serum and plasma (K+EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction test (PRNT) or by using the current CDC guidelines for diagnosis of this disease.
The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis. This assay is not FDA cleared or approved for testing blood or plasma donors.
Warning: Cross-reactivity with IgM to Dengue virus, Malaria/anti-Plasmodium falciparum and Parvovirus B19 has been observed with the EUROIMMUN Anti-West Nile Virus ELISA (IgM). Reactive results must be reported with a caution statement regarding possible IgM cross-reactivity with other flaviviruses.
Product codes (comma separated list FDA assigned to the subject device)
NPO
Device Description
Patient serum or plasma samples are diluted 1:101 in sample buffer and incubated for 10 minutes at room temperature to allow IgG/RF separation. 100 ul of each diluted patient sample and pre-diluted controls and calibrator are added to the antigen coated microtiter wells and incubated for 60 minutes at +37°C. After incubation the microtiter well strips are washed 3 times with wash buffer to remove unbound antibodies and 100 ul of the anti-human IgM enzyme conjugate reagent is added to each microtiter well. After an additional 30 minutes incubation at room temperature, the microtiter wells are again washed 3 times with wash buffer to remove any unbound enzyme conjugate and 100 ul of the chromogen substrate is added. The strips are incubated for 15 minutes at room temperature and 100 ul stop solution is added. The microtiter placed in an ELISA reader and read at a wavelength of 450 nm and a reference wavelength of between 620 nm and 650 nm within 30 minutes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance
Repeatability:
Panel of 8 members prepared using native/natural patient samples seropositive at different concentrations. Inter-assay repeatability based on 42 determinations per sample performed in 14 different runs on 7 different days (with 2 runs per day and 3 replicates per run).
Results:
Mean Ratio: 0.1 to 4.9
Within-Run %CV: 1.5% to 6.9%
Within-Day %CV: 5.2% to 10.5%
Between-Days %CV: 0.0% to 8.9%
Total %CV: 6.8% to 14.1%
Reproducibility:
Native/natural samples seropositive at different concentrations, assayed in 60 determinations per sample performed at 3 different sites (in-house and 2 laboratories in the north-east) for 5 days with 2 runs per day and 2 replicates per run.
Results:
Mean Ratio: 0.0 to 4.9
Within-Run %CV: 4.6% to 11.7%
Within-Day %CV: 0.0% to 5.2%
Between-Days %CV: 0.0% to 3.0%
Between-Sites %CV: 0.0% to 5.9%
Total %CV: 8.5% to 15.1%
Analytical Specificity/Cross Reactivity
692 serologically characterized seropositive specimens from patients with diseases other than WNV.
Results:
Overall % Negative: 95.2% (659/692)
Cross-reactivity observed with:
Anti-Chikungunya virus: 1 positive out of 59 (98.3% negative)
Anti-Dengue virus: 14 positive out of 57 (75.4% negative)
Anti-EBV: 2 positive out of 56 (96.4% negative)
Malaria/anti-Plasmodium falciparum: 4 positive out of 10 (60.0% negative)
Anti-Measles virus: 1 positive out of 18 (94.4% negative)
Anti-Parvovirus B19: 2 positive out of 7 (71.4% negative)
Anti-TBE virus: 3 positive out of 31 (90.3% negative)
Anti-Toxoplasma gondii: 1 positive out of 13 (92.3% negative)
Yellowfever virus immunization: 2 positive out of 31 (93.5% negative)
Anti-Zika virus: 2 positive out of 47 (93.6% negative)
Interference:
Hemolytic, lipemic and icteric samples showed no influence on the result up to a concentration of 1000 mg/dl for hemoglobin, 2000 mg/dl for triglycerides and 40 mg/dl for bilirubin. Interferences to high protein (albumin), cholesterol, and intralipids were not investigated.
Assay Cut-off:
Based on OD results of 18 sera from clinically characterized positive West Nile virus patients and 150 sera from normal healthy blood donors.
ROC analysis demonstrated optimal sensitivity (100.0%) and specificity (97.3%) at OD value of 0.217.
Using cut-off of ratio 1.0 and borderline range of ratio 0.8 to 1.1:
Sensitivity: 100.0% (95% C.I.: 81.5 - 100.0%)
Specificity: 95.3% (95% C.I.: 90.6-98.1%)
Clinical Study I:
Prospective clinical study with 155 samples from patients suspected of West Nile Virus infection across the US in 2015. Tested at one internal and two external sites in parallel with the predicate assay.
Positive agreement: 85.7% (36/42) (95% C.I. 71.5-94.6%)
Negative agreement: 97.3% (109/112) (95% C.I. 92.4-99.4%)
Subset of 25 presumptive positives by predicate device further tested by PRNT and the EUROIMMUN Anti-West Nile Virus ELISA (IgM).
Sensitivity vs PRNT: 84.0% (21/25) (95% C.I. 63.9-95.5%)
Clinical Study II:
Study performed at a clinical laboratory in the midwest with 398 serum samples collected prospectively from patients suspected of west nile virus infection. Tested in parallel with the Predicate ELISA.
Positive agreement: 90.9% (30/33) (95% C.I. 75.7-98.1%)
Negative agreement: 99.7% (364/365) (95% C.I. 98.5-100.0%)
Clinical Study III:
Study with 99 clinically collected serum samples, positive for WNV IgM in cooperation with the public health agency/laboratory in Canada. Tested by the predicate and the EUROIMMUN Anti-West Nile Virus ELISA (IgM).
Positive agreement: 89.9% (89/99) (95% C.I. 82.2-95.0%)
Matrix Comparison (Serum vs Plasma):
20 determinations for EDTA plasma and 20 for Li-heparin plasma. Samples created from 5 different sets of normal blood donor sample sets (serum, EDTA plasma, Li-heparin plasma) spiked with 5 different positive serum samples.
EDTA plasma (y = plasma, x = serum): y = -0.01 + 1.00x, R2 = 0.9787, Mean %recovery = 101% (Range 86 - 116%)
Li-heparin plasma (y = plasma, x = serum): y = 0.02 + 0.92x, R2 = 0.9707, Mean %recovery = 98% (Range 83 - 123%)
Regression equation near ideal correlation (intercept 0; slope 1.0) indicating equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100.0% (95% C.I.: 81.5 - 100.0%) (Assay Cut-off)
Specificity: 95.3% (95% C.I.: 90.6-98.1%) (Assay Cut-off)
Positive agreement (Clinical Study I): 85.7% (36/42) (95% C.I. 71.5-94.6%)
Negative agreement (Clinical Study I): 97.3% (109/112) (95% C.I. 92.4-99.4%)
Sensitivity vs PRNT (Clinical Study I subset): 84.0% (21/25) (95% C.I. 63.9-95.5%)
Positive agreement (Clinical Study II): 90.9% (30/33) (95% C.I. 75.7-98.1%)
Negative agreement (Clinical Study II): 99.7% (364/365) (95% C.I. 98.5-100.0%)
Positive agreement (Clinical Study III): 89.9% (89/99) (95% C.I. 82.2-95.0%)
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.
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
§ 866.3940 West Nile virus serological reagents.
(a)
Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
August 12, 2016
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EUROIMMUN US Inc. Michael Locke Director of Regulatory Affairs 1 Bloomfield Ave. Mountain Lakes, New Jersey 07046
Re: K153308
Trade/Device Name: EUROIMMUN Anti-West Nile Virus ELISA (IgM) Regulation Number: 21 CFR 866.3940 Regulation Name: West Nile Virus Serological Reagents Regulatory Class: II Product Code: NPO Dated: July 8, 2016 Received: July 12, 2016
Dear Mr. Locke:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Steven R. Gitterman -S
for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153308
Device Name
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
Indications for Use (Describe)
The EUROIMMUN Anti-West Nile Virus ELISA (IgM) is intended for the qualitative detection of IgM antibodies to West Nile virus in human serum and plasma (K+EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction test (PRNT) or by using the current CDC guidelines for diagnosis of this disease.
The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis. This assay is not FDA cleared or approved for testing blood or plasma donors.
Warning: Cross-reactivity with IgM to Dengue virus, Malarialanti-Plasmodium falciparum and Parvovirus B19 has been observed with the EUROIMMUN Anti-West Nile Virus ELISA (IgM). Reactive results must be reported with a caution statement regarding possible IgM cross-reactivity with other flaviviruses.
Type of Use (Select one or both, as applicable)
|×| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUBSTANTIAL EQUIVALENCE
510(k) Number
Applicant
EUROIMMUN US INC. 1 Bloomfield Ave., Mountain Lakes, New Jersey 07046 Phone: 800-913-2022 Fax: 973-656-1098
Contact:
Michael Locke Director of Regulatory Affairs & Quality Management 1 Bloomfield Ave., Mountain Lakes, New Jersey 07046 Phone: 800-913-2022 Fax: 973-656-1098
Product Name
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
Device Identification
Regulation: 21 CFR 866.3940 (West Nile virus serological reagents) Classification: Class II Product Code: NOP Panel: Microbiology
Substantial Equivalence Information:
Comparison to Predicate Device
| Similarities | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Intended use | EUROIMMUN Anti-West Nile Virus ELISA (IgM) (K153308) | Focus Diagnostics West Nile Virus IgM DxSelectTM ELISA (K040854) |
| Detection of IgM class antibodies against West Nile virus | Same | |
| Assay format | Qualitative | Same |
| Technology | ELISA | Same |
| Assay platform | 96-well microtiter plates | Same |
| Calibrators and Controls | 1 calibrator (cut-off) | |
| 2 controls: 1 positive; 1 negative | Same | |
| Substrate | TMB | Same |
| Wash buffer | 10x concentrate | Same |
| Serum sample dilution | 1:101 | Same |
| Procedure | Sample incubation with micro-well antigen coated plate, followed by a wash step, incubation with an anti-human IgM enzyme conjugate; wash step, incubation with substrate; stopping of the reaction with stop solution, photometric reading. | Same |
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| Differences | ||
|---|---|---|
| Item | New Device | Predicate Device |
| (K153308) EUROIMMUN Anti-West Nile | ||
| Virus ELISA (IgM) | (K040854) Focus Diagnostics West | |
| Nile Virus IgM DxSelect™ ELISA | ||
| Antigen | Detergent-extracted glycoprotein E from the | |
| membrane fraction of human cells, inactivated; | ||
| coated on microtiter plate | Recombinant West Nile virus | |
| antigen; lyophilized; not coated on | ||
| microtiter plate | ||
| Conjugate | Anti-human IgM (rabbit) labelled with | |
| horseradish peroxidase | Anti-flavivirus (mouse monoclonal) | |
| labelled with horseradish peroxidase | ||
| Stop solution | 0.5 M / 1N sulphuric acid | 1 M sulfuric acid |
| Reagent preparation | All reagents, calibrator and controls are ready | |
| to use, except for the wash buffer. | Calibrator and controls require | |
| dilution before use. | ||
| Sample matrix | Serum or plasma (EDTA, Li-heparin) | Serum |
| Procedure | IgG/RF removal by incubation with sample | |
| buffer containing IgG/RF-Absorbent. | Capture-Technology: Samples react | |
| with wells coated with ati-human | ||
| IgM; antigen specific for West Nile | ||
| virus added in an additional | ||
| incubation/wash step. | ||
| Reported results | Ratio | Index |
| Cut-off levels | Ratio | |
| Result | Index | |
| Result | ||
| 95% C.I. | 71.5-94.6% |
| Negative agreement | 97.3% (109/112) | 95% C.I. | 92.4-99.4% |
|---|---|---|---|
| -------------------- | ----------------- | ---------- | ------------ |
Of the 42 presumptive positives by the predicate device, 25 patients were further tested by PRNT (Plaque Reduction Neutralization Test) and the EUROIMMUN Anti-West Nile Virus ELISA (IgM). The results are shown below.
| Serum
| n = 25 | PRNT Results | |||
|---|---|---|---|---|
| Positive | Borderline | Negative | ||
| EUROIMMUN Anti- West Nile | ||||
| Virus ELISA (IgM) | Positive | 21 | 0 | 0 |
| Borderline | 3 | 0 | 0 | |
| Negative | 1 | 0 | 0 |
Sensitivity 95% C.I. 63.9-95.5% 84.0% (21/25)
Clinical Study II:
A study was performed at a clinical laboratory in the midwest, with 398 serum samples collected prospectively from patients suspected of west nile virus infection. The serum panel consisted of 193 men and 205 women, age ranged from 3 to 102 years with a mean age of 47 years. The samples were tested with the EUROIMMUN Anti-West Nile Virus ELISA (IgM) in parallel with the Predicate ELISA.
| Serum
| n = 398 | Predicate | ||||
|---|---|---|---|---|---|
| Positive | Borderline | Negative | |||
| EUROIMMUN Anti-West Nile | |||||
| Virus ELISA (IgM) | Positive | 30 | 0 | 1 | |
| Borderline | 1 | 0 | 0 | ||
| Negative | 2 | 0 | 364 | ||
| Positive agreement | 90.9% (30/33) | 95% C.I. | 75.7-98.1% | ||
| Negative agreement | 99.7% (364/365) | 95% C.I. | 98.5-100.0% |
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Clinical Study III:
A study was performed in cooperation with the public health agency/laboratory in Canada with 99 clinically collected serum samples, positive for WNV IgM. The samples were tested by the predicate and the EUROIMMUN Anti-West Nile Virus ELISA (IgM). The results are shown below.
| Serum
| n = 99 | Predicate | |||
|---|---|---|---|---|
| Positive | Borderline | Negative | ||
| EUROIMMUN Anti- West Nile | ||||
| Virus ELISA (IgM) | Positive | 89 | 0 | 0 |
| Borderline | 4 | 0 | 0 | |
| Negative | 6 | 0 | 0 |
| Positive agreement | 89.9% (89/99) | 95% C.I. | 82.2-95.0% |
|---|---|---|---|
| --------------------------- | --------------- | ---------- | ------------ |
Expected Values
Euroimmun assessed reactivity with 553 samples prospectively collected from US population. The samples consisted of 50% females, and 50% males The range of positivity of different populations from the US prospective studies with the EUROIMMUN Anti-West Nile Virus ELISA (IgM) test kit are presented below.
US Studies
| Age | n | Negative | Borderline | Positive | % Positive | 95% C.I. |
|---|---|---|---|---|---|---|
| 0-9 | 16 | 16 | 0 | 0 | 0.0 - 20.6% | |
| 10-19 | 32 | 28 | 0 | 4 | 12.5% (4/32) | 3.5 - 29.0% |
| 20-29 | 66 | 65 | 0 | 1 | 1.5% (1/66) | 0.0 - 8.2% |
| 30-39 | 86 | 81 | 1 | 4 | 4.7% (4/86) | 1.3 - 11.5% |
| 40-49 | 89 | 79 | 0 | 10 | 11.2% (10/89) | 5.5 - 19.7% |
| 50-59 | 100 | 83 | 2 | 15 | 15.0% (15/100) | 8.7 - 23.5% |
| 60+ | 164 | 125 | 5 | 34 | 20.7% (34/164) | 14.8 - 27.7% |
| total | 553 | 477 | 8 | 68 | 12.3% (68/553) | 9.7 - 15.3% |
Note: It is recommended that each laboratory determine its own normal range based on the population and equipment used.
Matrix Comparison (Serum vs Plasma)
The usability of plasma was investigated using sample sets each of serum and corresponding plasma (EDTA, Li-heparin). As no real plasma sample sets from patients containing anti-West Nile virus antibodies were available, the samples were created from 5 different sets of normal blood donor sample sets (serum, EDTA plasma, Li-heparin plasma) that were (after drawing) spiked with 5 different positive serum samples. After spiking, the sample sets were further diluted and processed according to the package insert.
Passing-Bablok regression was calculated for the comparison of serum to plasma. The regression equation is near the ideal correlation (intercept 0; slope 1.0) indicating equivalence of concentrations between serum and the corresponding plasma matrices. Coefficients of determination were found to be above 0.970 and % recovery compared to serum was in the range of 83 to 123% (serum = 100%).
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Matrix Comparison (serum vs plasma)
| EDTA plasma | Li-heparin plasma | |
|---|---|---|
| Determinations (n) | 20 | 20 |
| Concentration range (serum) | Ratio 0.3 - 2.6 | Ratio 0.3 - 2.6 |
| Concentration range (plasma) | Ratio 0.3 - 2.5 | Ratio 0.3 - 2.4 |
| Regression equation | y = -0.01 + 1.00x | y = 0.02 + 0.92x |
| (y = plasma, x = serum) | ||
| 95% C.I. of intercept | -0.05 - 0.07 | -0.05 - 0.12 |
| 95% C.I. of slope | 0.99 - 1.05 | 0.89 - 1.10 |
| Coefficient of determination R2 | 0.9787 | 0.9707 |
| Mean %recovery | 101% | 98% |
| Range of %recovery | 86 - 116% | 83 - 123% |
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.