(403 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the performance studies focus on standard analytical and clinical validation methods for an in vitro diagnostic test.
No
Explanation: The device is an in vitro diagnostic test system "intended for semi-quantitative measurement of total IgE in human capillary whole blood...as an aid in the clinical diagnosis of IgE-mediated allergic disorders." It is used for diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders."
No
The device description explicitly lists hardware components such as an "instrument," "cartridge," "sample collection kit," and "developing solution," indicating it is not a software-only device.
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 Kenota 1 Total IgE is an "in vitro test system" and is "intended for in vitro diagnostic use".
- Measurement: It measures total IgE in human capillary whole blood, which is a biological sample taken from the body.
- Diagnostic Aid: It is intended to be used "as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings". This clearly indicates its role in the diagnostic process.
- Care Setting: It is intended for use in "allergist/immunologist offices", which are healthcare settings where diagnostic testing is performed.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist offices.
Product codes (comma separated list FDA assigned to the subject device)
DGC
Device Description
The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.
-
- Kenota 1 Total IgE Cartridge (MKT-00006)
- Cartridges for lateral flow immunoassay ●
- Conjugate: anti-human IgE. fluorescently-labeled ●
- Two cartridges provided in a single sealed pouch
-
- Kenota 1 Total IgE External Controls (EC) (MKT-00007)
- External controls at two levels (low and high) ●
- 300 uL of each low and high control are provided in a 1.5 mL microcentrifuge tube ●
- Recombinant human IgE-Fc
- For single use / discarded after each external control session ●
- Ready for use, provided separately ●
-
- Kenota 1 (instrument) (MKT-00003)
- Automated instrument with a detachable tablet screen ●
- Cartridge sleeve loading up to 30 cartridges
- Instrument auto dispenses test sample into cartridges from the Kenota 1 Sample ● Collection Kit
- Instrument auto dispenses Kenota 1 Developing Solution into cartridges
- 25 minutes runtime for the Kenota 1 Total IgE
-
- Kenota 1 Sample Collection Kit (SCK) (MKT-00004)
- Consists of a syringe assembly, lancet, blood collector, diluent collector, and diluent ●
- Only for use with the Kenota 1
- Blood collector: Minivette POCT lithium-heparin green plunger (100 µL, Sarstedt) ●
- Diluent collector: Minivette POCT neutral white plunger (100 uL, Sarstedt)
- Ready for use, provided separately ●
-
- Kenota 1 Developing Solution (DS) (MKT-00005)
- Phosphate buffered saline with stabilizer and preservative (500 mL) ●
- Only for assays running on Kenota 1
- Ready for use, provided separately ●
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
6 to 80 years for subjects participating in the method comparison study. Reference interval study used 8 to 79 years of age from adult and pediatric volunteer donors.
Intended User / Care Setting
allergist/immunologist offices with a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The method comparison study used 357 samples, which were fingerstick whole blood collected by eleven untrained operators at three CLIA-waived sites in the US using Minivette POCT lithium-heparin tubes for the Kenota 1 Total IgE System. The same patients also provided venous whole blood collected by phlebotomists for the comparator (ImmunoCAP Total IgE) at the same three CLIA-waived sites. The subjects were recruited as representative of the intended use population, for patients with eczema or atopy coming in for regular appointments to allergy specialty care clinics. Individuals with skin damage, burns or scars at the site of venipuncture on both arms were excluded.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision / Reproducibility:
- Within-laboratory imprecision for evaluation of variability of cartridge lots: 150 replicates per sample (5 days x 3 lots x 2 runs x 5 replicates) using fresh venous whole blood samples on a single Kenota 1 instrument. %CV ranged from 7.9% to 19.6%.
- Within-laboratory precision for evaluation of variability of instruments: 150 replicates per sample (5 days x 2 runs x 3 instruments x 5 replicates) using fresh venous whole blood samples with one cartridge lot. %CV ranged from 6.5% to 15.3%.
- Estimation of repeatability of Fingerstick whole blood samples: 355 fresh fingerstick whole blood samples covering the analytical measuring interval using 11 untrained operators at three CLIA-waived sites. %CV ranged from 7.2% to 10.6% across different IgE ranges.
- Multi-site Reproducibility: 126 replicates (3 sites x 3 operators x 2 EC sessions x 7 days) per control for low and high Kenota 1 Total IgE External Controls. Total %CV for low control was 12.2% and for high control was 11.6%.
Linearity:
- Evaluated according to CLSI document EP06-2nd by testing 11 dilution levels. Each sample dilution was measured in one run with 15 replicates. The Kenota 1 Total IgE was found to be linear at 11 levels spanning the semi-quantitative categories.
Interference and Cross-reactivity:
- Endogenous Interferents: Evaluated two IgE levels (low and high) for potential interfering substances (Bilirubin, Triglycerides, Rheumatoid Factor, Albumin, Creatinine, Oxalic Acid, IgA, IgD, IgG, IgM, HAMA, Hemoglobin). No significant interference (≤±10% difference) was observed, except for Rheumatoid Factor and Omalizumab. Rheumatoid Factor showed significant interference (≥ 10% bias) at 112.5 IU/mL for the low sample.
- Exogenous Interferents: Evaluated common substances (Acetaminophen, Acetylsalicylic Acid, Ascorbic Acid, Caffeine, Cetirizine, Diphenhydramine, Ethanol, Fexofenadine, Gentisic Acid, Heparin). No significant interference (≤±10% bias) was observed up to the tested concentrations. Omalizumab showed significant interference (≥ 10% bias) for low and high IgE samples at all concentrations between 25 ug/mL to 100 ug/mL.
- Cross-reactivity: Evaluated with other immunoglobulin isotypes as part of endogenous interferents.
Assay Reportable Range:
- The claimed analytical measuring interval (AMI) for the Kenota 1 Total IgE is 5.0 kU/L to 900 kU/L.
Detection Limit:
- Limit of Blank (LoB): Determined to be 1.9 kU/L.
- Limit of Detection (LoD): Claimed LoD is 5 kU/L.
- Limit of Quantitation (LoQ): Claimed LoQ is 5 kU/L.
Accuracy (Blood Collector / Instrument):
- Recovery bias was
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
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May 31, 2024
Kenota Inc. Martin Mann Director of Regulatory Affairs 335 Gage Ave #1 Kitchener, Ontario N2M 5E1 Canada
Re: K231151
Trade/Device Name: Kenota 1 Total IgE, Kenota 1 (instrument) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: Class II Product Code: DGC Dated: April 21, 2023 Received: April 24, 2023
Dear Martin Mann:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing
1
K231151 - Martin Mann
Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-comprehensiveregulatory-assistance/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,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231151
Device Name Kenota 1 Total IgE Kenota 1 (instrument)
Indications for Use (Describe)
The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist offices.
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) |
|---|---|
| ------------------------------------------------------------------------------- | ------------------------------------------------------------------- |
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Premarket Notification 510(k) No: K231151
Date of Summary Preparation: May 16, 2024 Manufacturer: Kenota Incorporated, DBA Kenota Health 1-335 Gage Ave. Kitchener ON N2M SE1 Distributor: Kenota USA TBD Martin Mann Company Contact Person: Dir. Regulatory Affairs Kenota Inc. 1-335 Gage Ave. (269) 207-7049
Device Name: Kenota 1 Total IgE, Kenota 1 instrument
Common Name:
- Automated in-vitro semi-quantitative assay for the measurement of total IgE . antibodies.
Martin@kenota.com
Regulator Information:
| Product
| Code(s) | Classification | Regulation | Section Panel |
|---|---|---|---|
| DGC | Class II | 21 CFR 866.5510 - | |
| Immunoglobulins A, G, M, D, | |||
| and E Immunological Test | |||
| System | IM - Immunology |
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I Submission/Device Overview:
A Purpose for Submission:
Dual 510(k) and CLIA Waiver by Application (Dual Submission) for a new device
B Measurand:
Total immunoglobulin E (IgE)
C Type of Test:
Semi-Quantitative, fluorescence lateral flow immunoassay
II Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist offices.
C Special Conditions for Use Statement(s):
For Prescription Use Only
D Special Instrument Requirements:
Kenota 1 (instrument)
III Device/System Characteristics:
A Device Description:
5
The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.
-
- Kenota 1 Total IgE Cartridge (MKT-00006)
- Cartridges for lateral flow immunoassay ●
- Conjugate: anti-human IgE. fluorescently-labeled ●
- Two cartridges provided in a single sealed pouch
-
- Kenota 1 Total IgE External Controls (EC) (MKT-00007)
- External controls at two levels (low and high) ●
- 300 uL of each low and high control are provided in a 1.5 mL microcentrifuge tube ●
- Recombinant human IgE-Fc
- For single use / discarded after each external control session ●
- Ready for use, provided separately ●
-
- Kenota 1 (instrument) (MKT-00003)
- Automated instrument with a detachable tablet screen ●
- Cartridge sleeve loading up to 30 cartridges
- Instrument auto dispenses test sample into cartridges from the Kenota 1 Sample ● Collection Kit
- Instrument auto dispenses Kenota 1 Developing Solution into cartridges
- 25 minutes runtime for the Kenota 1 Total IgE
-
- Kenota 1 Sample Collection Kit (SCK) (MKT-00004)
- Consists of a syringe assembly, lancet, blood collector, diluent collector, and diluent ●
- Only for use with the Kenota 1
- Blood collector: Minivette POCT lithium-heparin green plunger (100 µL, Sarstedt) ●
- Diluent collector: Minivette POCT neutral white plunger (100 uL, Sarstedt)
- Ready for use, provided separately ●
-
- Kenota 1 Developing Solution (DS) (MKT-00005)
- Phosphate buffered saline with stabilizer and preservative (500 mL) ●
- Only for assays running on Kenota 1
- Ready for use, provided separately ●
B Principle of Operation:
The Kenota 1 Total IgE is a lateral flow immunoassay test system that measures total IgE in human capillary whole blood on the automated instrument. Kenota 1. After an operator loads the fingerstick sample into the Kenota 1, the instrument dispenses a set amount of the fingerstick sample (4.5 uL) onto the Kenota 1 Total IgE Cartridge and adds the Kenota 1 Developing
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Solution to allow the sample to flow along the membrane to the test line containing immobilized mouse anti-human IgE that captures the human IgE in the test sample. This immune complex is captured by mouse anti-(human IgE) IgG bound to the fluorescent reporter. The fluorescent test signal is directly proportional to the level of IgE in the sample. Excess Europium-antibody conjugates are captured at the control line, which consists of immobilized rat anti-mouse kappa light chain IgG.
C Instrument Description Information:
-
- Instrument Name:
Kenota 1 (instrument)
- Instrument Name:
-
- Specimen Identification:
Capillary whole blood is the only specimen type for Kenota 1 and the samples are loaded into the instrument one sample at a time.
- Specimen Identification:
-
- Specimen Sampling and Handling:
The Kenota 1 processes fresh fingerstick whole blood samples collected in a blood collector coated with lithium heparin anticoagulant (Minivette POCT lithium-heparin green plunger (100 uL, Sarstedt)) and transferred to the syringe assembly of the Kenota 1 Sample Collection Kit (SCK) for the Kenota 1 Total IgE. The syringe assembly is manually loaded into the Kenota 1 by the operator.
- Specimen Sampling and Handling:
-
- Calibration:
The Kenota 1 is factory calibrated. The Kenota 1 Total IgE Cartridge is factory calibrated to align directly with the 3th International Standard for serum IgE (11/234), using a set of nine working calibrators with values assigned to 0, 2.17, 6.2, 18.6, 37.2, 93, 310, 620, and 930 kU/L.
- Calibration:
-
- Quality Control:
Performance of the Kenota 1 Total IgE is verified with the Kenota 1 Total IgE External Controls (EC). The EC is a stabilized control material used for verifying the performance of the Kenota 1, Kenota 1 Total IgE Cartridge, and intended users' operational procedures. Results of the external control session are not interpreted by the Kenota 1 instrument. If the external control session fails, the Kenota 1 is automatically locked out and the operator is instructed to contact Kenota Support. The external control session is required
- Quality Control:
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when a new lot of Kenota 1 Total IgE Cartridge is used, or when using a new bottle of Kenota 1 Developing Solution, or a new operator is qualified, or when a monthly (every 30 days) maintenance session is performed.
IV Substantial Equivalence Information:
A Predicate Device Name:
Phadia ImmunoCAP Total IgE
Predicate 510(k) Number: B
C Comparison with Predicate(s):
| Device & Predicate | Candidate | Predicate |
|---|---|---|
| Device(s): | K231151 | K161899 |
| Device Trade Name | Kenota 1 Total IgE | ImmunoCAP Total IgE |
| General Device | ||
| Characteristic | ||
| Similarities | ||
| Intended Use/Indications | ||
| For Use | The Kenota 1 Total IgE is an in vitro test | |
| system intended for semi-quantitative | ||
| measurement of total IgE in human | ||
| capillary whole blood on the Kenota 1 | ||
| instrument. It is intended for in vitro | ||
| diagnostic use as an aid in the clinical | ||
| diagnosis of IgE-mediated allergic | ||
| disorders in conjunction with other clinical | ||
| findings, and is to be used in | ||
| allergist/immunologist offices. | ImmunoCAP Total IgE is an in vitro test | |
| system for the quantitative measurement | ||
| of circulating total IgE in human serum | ||
| and plasma. It is intended for in vitro | ||
| diagnostic use as an aid in the clinical | ||
| diagnosis of IgE mediated allergic | ||
| disorders in conjunction with other | ||
| clinical findings, and is to be used in | ||
| clinical laboratories. | ||
| ImmunoCAP Total IgE is to be used | ||
| with the instruments Phadia 100, Phadia | ||
| 250, Phadia 1000, Phadia 2500 or | ||
| Phadia 5000. | ||
| Product Code | DGC | DGC |
| Rx or OTC | Rx Only | Same |
| Test Principle | Solid phase Immunofluorescence assay | Same |
| Assay Technology | Direct Fluorescence | Same |
| Analyte | Immunoglobulin E (IgE) | Same |
| Capture Antibody | Mouse anti-human IgE monoclonal | Same |
| Detection Antibody | Mouse anti-(human IgE) IgG monoclonal | Same |
| Device & Predicate | ||
| Device(s): | Candidate | |
| K231151 | Predicate | |
| K161899 | ||
| Traceability | 3rd International Reference Preparation | |
| (IRP) 11/234 of Human Serum | ||
| Immunoglobulin E from World Health | ||
| Organization (WHO) | Same | |
| General Device | ||
| Characteristic | ||
| Differences | ||
| Measurement Type | Semi-quantitative | Quantitative |
| Test Results | Below LoQ: 900 kU/L | kU/L |
| Sample Type | Fingerstick whole blood (Lithium- | |
| Heparin) | Venous serum or plasma (EDTA or | |
| Heparin) | ||
| Intended Use | ||
| Environment | Allergist / immunologist offices with a | |
| Clinical Laboratory Improvement | ||
| Amendments (CLIA) Certificate of | ||
| Waiver. | Clinical laboratory | |
| Operating Principle | Lateral flow immunoassay | Sponge-based immunoassay |
| Test Sample Volume | 4.5 µL | 40 µL |
| Detection Capability | LoD: 5 kU/L | |
| LoQ: 5 kU/L | LoD: 2 kU/L | |
| LoQ: 2 kU/L | ||
| Reportable Range | 5 - 900 kU/L | 2 - 5000 kU/L |
| Calibration | 9-level multipoint calibration is performed | |
| at the manufacturing site. Lot specific | ||
| calibration values are coded on the | ||
| cartridge barcodes | 6-level multipoint calibration is | |
| performed externally by the operator | ||
| Calibrators | 0, 2.17, 6.2, 18.6, 37.2, 93, 310, | |
| 620, 930 kU/L | 2, 10, 50, 200, 1000, 5000 | |
| kU/L | ||
| Controls | Two levels: Low and High | Three levels: Low, Medium, High |
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V Standards/Guidance Documents Referenced:
- CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; . Approved Guideline—Third Edition
- CLSI EP06-Ed2: Evaluation of Linearity of Quantitative Measurement Procedures: A . Statistical Approach; Approved Guideline
- CLSI EP07, 3rd Edition: Interference Testing in Clinical Chemistry .
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Image /page/9/Picture/0 description: The image shows the logo for Kenota Health. The word "kenota" is written in a sans-serif font, with the "o" replaced by a colorful, stylized sunburst. Below the word "kenota" is the word "health" in a smaller, teal-colored font. The logo is simple and modern, and the use of color gives it a friendly and approachable feel.
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement ● Procedures; Approved Guideline-Second Edition
- I/LA-20 3rd Edition (Replaces I/LA20-A3): Analytical Performance Characteristics, ● Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities - Third edition
- CLSI EP25-Ed2 (Replaces EP25-P): Evaluation of Stability of In Vitro Diagnostic ● Reagents: Approved Guideline.
- CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition
- CLSI EP37: Supplemental Tables for Interference Testing in Clinical Chemistry ●
VI Performance Characteristics (if/when applicable):
A Analytical Performance:
-
- Precision / Reproducibility:
Precision of the Kenota 1 Total IgE Cartridge was evaluated with four precision studies: (a) within-laboratory study for evaluation of different cartridge lots, (b) within-laboratory study for evaluation of different Kenota 1 instruments, (c) estimation of repeatability of fingerstick whole blood samples, and (d) multi-site reproducibility of controls as follows.
- Precision / Reproducibility:
-
a. Within-laboratory imprecision for evaluation of variability of cartridge lots
Precision was evaluated according to CLSI document EP05-A3 using three lots of Kenota 1 Total IgE Cartridge on a single Kenota 1 instrument using fresh venous whole blood samples collected in lithium-heparin anticoagulant-coated blood collection tubes. In the study, total IgE was measured using the Kenota 1 Total IgE Cartridge in five replicates for each lot of cartridges, two times per day for five days (5 days x 3 lots x 2 runs x 5 replicates = 150 replicates per sample) by a single operator / instrument. The result for different components of precision is summarized below:
| Sample | N | Mean
(kU/L) | Repeatability | | Between-
Run | | Between-
Day | | Between-
Lot | | Within-
Laboratory | |
|--------------|-----|----------------|---------------|------|-----------------|-----|-----------------|-----|-----------------|------|-----------------------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low | 150 | 48.4 | 6.1 | 12.6 | 0.0 | 0.0 | 1.6 | 3.3 | 7.1 | 14.6 | 9.5 | 19.6 |
| Medium | 150 | 131.0 | 15.0 | 11.5 | 0.0 | 0.0 | 4.2 | 3.2 | 10.7 | 8.2 | 18.9 | 14.5 |
| High | 150 | 312.1 | 38.8 | 12.4 | 0.0 | 0.0 | 0.0 | 0.0 | 30.9 | 9.9 | 49.6 | 15.9 |
| Very
high | 150 | 803.3 | 63.1 | 7.9 | 0.0 | 0.0 | 2.9 | 0.4 | 45.3 | 5.6 | 77.7 | 9.7 |
In addition, the table below provides semi-quantitative analysis over three cartridge lots.
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| Sample | N | Mean
(kU/L) | 90 |
|--------------|-----|----------------|-----|------------------|---------------------|---------------------|---------------------|---------------------|-------------------|
| Low | 150 | 48.4 | 0 | 4.7 %
(7/150) | 95.3 %
(143/150) | 0 | 0 | 0 | 0 |
| Medium | 150 | 131.0 | 0 | 0 | 2.7 %
(4/150) | 97.3 %
(146/150) | 0 | 0 | 0 |
| High | 150 | 312.1 | 0 | 0 | 0 | 1.3 %
(2/150) | 98.7 %
(148/150) | 0 | 0 |
| Very
high | 150 | 803.3 | 0 | 0 | 0 | 0 | 0 | 90.7 %
(136/150) | 9.3 %
(14/150) |
- b. Within-laboratory precision study for evaluation of variability of instruments
Instrument-to-Instrument variability was evaluated using three Kenota 1 instruments with one cartridge lot using fresh venous whole blood samples collected in lithium-heparin anticoagulant-coated blood collection tubes. The study included three operators (one operator for each instrument). In the study, the total IgE concentration was measured using one lot of the Kenota 1 Total IgE Cartridge in five replicates for each instrument/operator two times per day for five days (5 days x 2 runs x 3 instruments x 5 replicates = 150 replicates per sample). The result for different components of numeric values is summarized below.
| Sample | N | Mean
(kU/L) | Repeatability | | Between-
Run | | Between-
Day | | Between-
Instrument/
Operator | | Within-
Laboratory | |
|--------------|-----|----------------|---------------|------|-----------------|---------|-----------------|---------|-------------------------------------|---------|-----------------------|---------|
| | | | SD | %CV | SD | %C
V | SD | %C
V | SD | %C
V | SD | %C
V |
| Low | 150 | 54.3 | 7.1 | 13.1 | 0.0 | 0.0 | 1.8 | 3.3 | 0.0 | 0.0 | 7.4 | 13.6 |
| Medium | 150 | 139.4 | 18.4 | 13.2 | 0.0 | 0.0 | 6.3 | 4.5 | 0.0 | 0.0 | 19.5 | 14.0 |
| High | 150 | 342.4 | 50.4 | 14.7 | 0.0 | 0.0 | 14.3 | 4.2 | 0.0 | 0.0 | 52.4 | 15.3 |
| Very
high | 150 | 802.4 | 52.4 | 6.5 | 9.1 | 1.1 | 0.0 | 0.0 | 13.0 | 1.6 | 54.7 | 6.8 |
In addition, the table below provides semi-quantitative analysis over three cartridge lots.
| Sample | N | Mean
(kU/L) | 900 |
|--------|-----|----------------|-----|------------------|---------------------|----------------------|---------|---------|-------|
| Low | 150 | 48.4 | 0 | 0.7 %
(1/150) | 99.3 %
(149/150) | 0 | 0 | 0 | 0 |
| Medium | 150 | 131.0 | 0 | 0 | 0 | 100.0 %
(150/150) | 0 | 0 | 0 |
11
Image /page/11/Picture/0 description: The image shows the logo for Kenota Health. The word "kenota" is written in a sans-serif font, with the "o" replaced by a colorful, stylized sunburst. Below "kenota" is the word "health" in a smaller, teal-colored sans-serif font. The logo is simple and modern, with a focus on the company's name and the health industry.
| Dual 510(k) CLIA Waiver for Kenota 1 Total IgE: 510(k)Summary | |||
|---|---|---|---|
| -- | -- | --------------------------------------------------------------- | -- |
| High | 150 | 312.1 | 0 | 0 | 0 | 0 | 99.3 %
(149/150) | 0.7 %
(1/150) | 0 |
|--------------|-----|-------|---|---|---|---|---------------------|---------------------|------------------|
| Very
high | 150 | 803.3 | 0 | 0 | 0 | 0 | 0 | 98.7 %
(148/150) | 1.3 %
(2/150) |
c. Estimation of repeatability of Fingerstick whole blood samples
An estimate of repeatability was determined using 355 fresh fingerstick whole blood samples covering the analytical measuring interval (AMI) that were collected in the Minivette POCT lithium-heparin tubes. The study was conducted in three CLIA-waived sites in the U.S. and the testing was performed by a total of eleven (11) untrained operators, including three untrained operators at Site 1, three untrained operators at Site 2, and five untrained operators at site 3. Two different operators each collected a separate fingerstick whole blood from the same patient and tested the sample on two (2) or three (3) Kenota 1 instruments at each site with a single lot of Kenota 1 total IgE Cartridge. Variability of two fingerstick numerical results was calculated for each patient in five semi-quantitative intervals. The SD for each semi-quantitative interval was calculated as the SD averaged over patients from the interval. The results of the repeatability evaluation are presented in the table below.
| Range (kU/L) | Sample (N) | Mean (kU/L) | SD | %CV |
|---|---|---|---|---|
| 5 – 34 | 117 | 17.9 | 1.9 | 10.6 |
| 35-100 | 86 | 63.1 | 5.5 | 8.7 |
| 101–200 | 57 | 142.7 | 14.0 | 9.8 |
| 201–540 | 67 | 335.7 | 28.3 | 8.4 |
| 541-900 | 28 | 702.6 | 50.5 | 7.2 |
| Entire Range (5- |
- | 355 | 162.9 | 13.5 | 8.3 |
d. Multi-site Reproducibility
Multi-site Reproducibility was evaluated at three CLIA-waived sites using a single lot of Kenota 1 Total IgE External Controls tested. The low and high controls of the ECs were tested by three operators per site in two external control sessions per day on seven different days at each site using a single lot of Kenota 1 total IgE Cartridge to obtain 126 replicates (3 sites x 3 operators x 2 EC sessions x 7 days) per control. The result for different components of numeric values is summarized below.
12
Image /page/12/Picture/0 description: The image shows the logo for Kenota Health. The word "kenota" is written in a sans-serif font, with the "o" replaced by a colorful circular design. Below the word "kenota" is the word "health" in a smaller, teal-colored font.
| Control | N | Mean
(kU/L) | Between-Run | | Between-Day | | Between-Operator | | Between-Site | | Total | |
|---------|-----|----------------|-------------|------|-------------|---------|------------------|---------|--------------|---------|-------|---------|
| | | | SD | %CV | SD | %C
V | SD | %C
V | SD | %C
V | SD | %C
V |
| Low | 126 | 34.0 | 3.9 | 11.4 | 1.0 | 2.8 | 1.2 | 3.4 | 0.0 | 0.0 | 4.1 | 12.2 |
| High | 126 | 259.5 | 26.2 | 10.1 | 11.2 | 4.3 | 9.7 | 3.8 | 0.0 | 0.0 | 30.1 | 11.6 |
2. Linearity:
Linearity was evaluated according to CLSI document EP06-2nd by testing eleven (11) dilution levels that cover the analytical measuring interval (AMI) of the Kenota 1 Total IgE. The test samples were prepared by pooling the high and low human lithium-heparin venous whole blood samples. Each sample dilution was measured in one run with 15 replicates. The Kenota 1 Total IgE was found to be linear at 11 levels spanning the semi-quantitative categories as shown in the table below.
| Sample | Expected
Numerical
Value
(kU/L) | Expected
Category
(kU/L) | 900 |
|--------|------------------------------------------|--------------------------------|-----------------|-----------------|-----------------|------------------|-----------------|------------------|------------------|
| 1 | 981 | >900 | | | | | | 6.7%
(1/15) | 93.3%
(14/15) |
| 2 | 787 | 541-900 | | | | | | 100%
(15/15) | |
| 3 | 590 | 541-900 | | | | | 13.3%
(2/15) | 86.7%
(13/15) | |
| 4 | 393 | 201-540 | | | | | 100%
(15/15) | | |
| 5 | 197 | 101-200 | | | | | 100%
(15/15) | | |
| 6 | 99 | 35-100 | | | 6.7%
(1/15) | 93.3%
(14/15) | | | |
| 7 | 50 | 35-100 | | | 100%
(15/15) | | | | |
| 8 | 26 | 5-34 | | 100%
(15/15) | | | | | |
| 9 | 13 | 5-34 | | 100%
(15/15) | | | | | |
| 10 | 7 | 5-34 | | 100%
(15/15) | | | | | |
| 11 | 4 | 900 |
| 900 | | | | | | | | | | | 4 |
| Total | 10 | 98 | 29 | 52 | 34 | 27 | 26 | 34 | 22 | 9 | 16 |
| Percent
in ATE | 100.0%
(10/10) | 96.9%
(95/98) | 100.0%
(29/29) | 94.2%
(49/52) | 100.0%
(34/34) | 88.9%
(24/27) | 100.0%
(26/26) | 94.1%
(32/34) | 100.0%
(22/22) | 88.9%
(8/9) | 93.8%
(15/16) |
| Percent
in ATE | Low range
96.8%
(183/189) | | | | Middle range
96.6%
(84/87) | | | | High range
95.1%
(77/81) | | |
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Image /page/19/Picture/0 description: The image shows the logo for Kenota Health. The word "kenota" is written in gray, with a colorful burst of light in the middle of the word. Below the word "kenota" is the word "health" in a light green color.
| 95%CI: (93.2%; 98.5%) | 95%CI: (90.3%; 98.8%) | 95%CI: (88.0%; 98.1%) | |
|---|---|---|---|
| Percent | |||
| in ATE | 96.4% | ||
| (344/357) | |||
| 95%CI: (93.9%; 97.9%) | |||
| Percent | |||
| in LER | 0.0% | ||
| (0/357) | |||
| 95%CI: (0.0%; 1.1%) |
In addition, of these 357 samples used for semi-quantitative analysis above, 339 samples were used for regression analysis based on the test results within the AMI of both the Kenota Total IgE test and the comparator. Results of a weighted Deming regression analysis for numeric values of the test samples are summarized in the table below.
| Comparison | Sample Range
(IU/mL) | N | Slope
(95% CI) | Intercept
(95% CI) | Correlation
Coefficient (r) |
|---------------------------------------------------------------------------------|-------------------------|---------|----------------------|-----------------------|--------------------------------|
| Kenota 1 System and
Kenota 1 Total IgE
Assay
vs
ImmunoCAP Total IgE | 5.1-824.1 | N = 339 | 1.03
(1.00, 1.06) | 1.10
(0.49, 1.66) | 0.95 |
2. Matrix Comparison:
Not applicable; lithium-heparin capillary whole blood is the only sample type.
C Clinical Studies:
-
- Clinical Sensitivity:
Not applicable
- Clinical Sensitivity:
-
- Clinical Specificity:
Not applicable
- Clinical Specificity:
-
- Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
See Method Comparison
- Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
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Image /page/20/Picture/0 description: The image shows the logo for Kenota Health. The word "kenota" is in gray, with the "o" being a colorful circle made of small lines. Below "kenota" is the word "health" in a light green color.
D Clinical Cut-Off:
Not applicable
E Expected Values/Reference Range:
A reference interval study was performed in accordance with CLSI guideline EP28-A3c using 117 fingerstick samples (ranged 8 to 79 years of age) collected from adult (N = 95. at 22 to 79 years of age) and pediatric (N = 22, at 8 to