(29 days)
No
The description mentions "ANALYSIS SOFTWARE algorithm" which converts genotypes to alleles based on literature, but there is no indication of learning or adaptive capabilities characteristic of AI/ML.
No.
The device is an in vitro diagnostic test intended as an aid in diagnosis, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section states that "The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD)." This explicitly indicates its role in diagnosis.
No
The device description explicitly states that the "A1AT Genotyping Test Kit is composed of 4 reagent components" and that these are "required to perform all the abovementioned processing steps." While there is analysis software, the device is a system that includes both reagents (hardware components) and software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test..."
- Used with biological samples: The test is intended for use with genomic DNA extracted from human whole blood and saliva samples. This is a key characteristic of IVDs, which are used to examine specimens taken from the human body.
- Provides information for diagnosis: The results are intended "as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD)." This aligns with the purpose of IVDs, which are used to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Requires laboratory procedures: The "Device Description" outlines a series of laboratory procedures (DNA extraction, PCR, hybridization, detection) performed on the biological samples.
Therefore, based on the provided information, the Progenika A1AT genotyping kit is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminent (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (AIAT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
PZH
Device Description
Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS, from human EDTA anticoagulated whole blood or from human saliva samples collected as buccal swabs using ORAcollect-Dx OCD-100. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.
The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the abovementioned processing steps. The A1AT Genotyping Test ANALYSIS SOFTWARE, instructions for use and other necessary files are uploaded on a Grifols website. Two kit configurations are available: for 48 or 192 tests (different amounts of the same reagent components are provided in each case).
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
prescription use only
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)
- Precision/Reproducibility:
- Lot-to-lot repeatability: The lot-to-lot repeatability was determined by testing the "Sample Panel" (five DNA samples covering Z/Z, M/Z, S/S, M/S, and S/Z Sample Results) in triplicate with three different reagent lots, by two operators, on six non-consecutive days, alternating between two Luminex instruments. An overall repeatability of 100% was obtained for Sample Results.
- External Reproducibility: See K171868.
- Reagent Stability: See K171868 for initial Real-Time and Open-Vial Stabilities information and study designs and K192858 for final claimed stabilities of 24 months reagent stability when stored at 2-8ºC and up to 9 months reagent stability after the vials were first opened.
- Specimen Stability: See K171868 for whole blood samples collected as DBS or in K2-EDTA stabilities. See K152464 and K192858 for saliva samples stability collected in ORAcollect-Dx OCD-100.
- Lower Limit of Detection (LoD): The DNA concentration at which 95% of sample replicates resulted in correct Sample Results was determined by testing 20 replicates of nine DNA dilutions of the "Sample Panel" (from 0.16 to 0.0033 ng/μl) using two reagent lots. It was shown that the highest LoD among the two lots used was 0.0215 ng/μl.
- DNA Extraction Variability: See K171868 for DNA Extraction Variability in whole blood samples collected as DBS or in K2-EDTA information. See K192858 for DNA Extraction Variability in saliva samples.
- Cross-reactivity and Cross-contamination: See K171868 for Cross-reactivity and Cross-contamination information.
- Interfering Substances: See K171868 for Interfering Substances information in whole blood samples collected as DBS or in K2-EDTA. See K192858 for Interfering Substances information in Saliva samples collected in ORAcollect-Dx OCD-100. See K192858 for information about potentially interfering variants.
- Method Comparison: See K171868 for Method Comparison information in whole blood samples. See K192858 for Method Comparison information in saliva samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2021
Progenika Biopharma S.A., a Grifols company Diego Tejedor Technical Director Ibaizabal bidea, Edificio 504, Parque Tecnológico de Bizkaia Derio, Bizkaia 48160 Spain
Re: K211115
Trade/Device Name: A1AT Genotyping Test Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1-antitrypsin immunological test system Regulatory Class: Class II Product Code: PZH Dated: April 12, 2021 Received: April 14, 2021
Dear Diego Tejedor:
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,
Ying (Katelin) Mao, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211115
Device Name A1AT Genotyping Test
Indications for Use (Describe)
The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminent (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (AIAT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Progenika Biopharma, S.A.
Ibaizabal bidea, Edificio 504
Parque Tecnológico de Bizkaia
48160 Derio - Bizkaia - SPAIN
Phone: +34 94 406 45 25
Fax: +34 94 406 45 26
CIF: ESA95091799
www.progenika.com - www.grifols.com
Special 510(k) Summary
- A. Name of the device: A1AT Genotyping Test
- B. Common name: Test for SERPINA1 gene genotyping
- C. Regulatory information:
- a. Classification: Class II
- b. Regulation Section: 21 CFR 866.5130, Alpha-1-antitrypsin immunological test system
- c. Classification Product Code: PZH, SERPINA1 Variant Detection System
- d. Review panel: Immunology (82)
- D. Applicant: Progenika Biopharma S.A.
Address: Parque Tecnológico de Bizkaia Ibaizabal bidea, Edificio 504 C.P. 48160, Derio - Bizkaia (Spain) Telephone number: +34 94 406 45 25 Fax number: +34 94 406 45 26 Contact person: Diego Tejedor, Technical Director e-mail: diego.tejedor@grifols.com
E. Intended Use:
The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200TM instrument (with xPONENT® software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect·Dx OCD-100. The A1AT allelic variant
4
www.progenika.com - www.grifols.com
genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD).
The kit is indicated for prescription use only.
F. Device Description:
Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS, from human EDTA anticoagulated whole blood or from human saliva samples collected as buccal swabs using ORAcollect-Dx OCD-100. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.
The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the abovementioned processing steps. The A1AT Genotyping Test ANALYSIS SOFTWARE, instructions for use and other necessary files are uploaded on a Grifols website. Two kit configurations are available: for 48 or 192 tests (different amounts of the same reagent components are provided in each case).
G. Substantial Equivalence Information:
Predicate Device: A1AT Genotyping Test 510(k) number: K192858 Applicant: Progenika Biopharma S.A.
5
Progenika Biopharma, S.A. lbaizabal bidea. Edificio 504 Parque Tecnológico de Bizkaia 48160 Derio - Bizkaia - SPAIN Phone: +34 94 406 45 25 Fax: +34 94 406 45 26 CIF: ESA95091799 www.progenika.com - www.grifols.com
Main conclusion: The similarities among the candidate device and the predicate device show that A1AT Genotyping Test to be used together with the updated software application is substantially equivalent to the predicate.
Based on the risk assessment and performance data, it can be considered that the differences due to the software update do not raise different questions of safety and effectiveness.
6
Progenika Biopharma, S.A.
lbaizabal bidea, Edificio 504 Parque Tecnológico de Bizkaia
48160 Derio - Bizkaia - SPAIN
Phone: +34 94 406 45 25
Fax: +34 94 406 45 25
Fax: +34 94 406 45 26 ClF: ESA95091799
www.progenika.com - www.grifols.com
| Candidate Device | Predicate Device | |
|---|---|---|
| Item | Modified A1AT Genotyping Test | A1AT Genotyping Test (K192858) |
| Intended Use | The Progenika A1AT genotyping kit is a qualitative, polymerase | |
| chain reaction (PCR) and hybridization-based in vitro diagnostic test | ||
| to be used with the Luminex 200™ instrument (with xPONENT® | ||
| software) for the simultaneous detection and identification of 14 | ||
| allelic variants and their associated alleles found in the Alpha-1 | ||
| antitrypsin (A1AT) codifying gene SERPINA1 . The test is intended | ||
| for use with genomic DNA extracted from human whole blood | ||
| samples collected as dry blood spots (DBS) or in K2-EDTA or from | ||
| human saliva samples collected as buccal swabs using | ||
| ORAcollect-Dx OCD-100. The A1AT allelic variant genotypes and | ||
| associated allele results, when used in conjunction with clinical | ||
| findings and other laboratory tests, are intended as an aid in the | ||
| diagnosis of individuals with A1AT deficiency (A1ATD). | ||
| The kit is indicated for prescription use only | The Progenika A1AT genotyping kit is a qualitative, polymerase chain | |
| reaction (PCR) and hybridization-based in vitro diagnostic test to be | ||
| used with the Luminex 200™ instrument (with xPONENT® software) | ||
| for the simultaneous detection and identification of 14 allelic variants | ||
| and their associated alleles found in the Alpha-1 antitrypsin (A1AT) | ||
| codifying gene SERPINA1 . The test is intended for use with genomic | ||
| DNA extracted from human whole blood samples collected as dry | ||
| blood spots (DBS) or in K2-EDTA or from human saliva samples | ||
| collected as buccal swabs using ORAcollect-Dx model OCD-100. The | ||
| A1AT allelic variant genotypes and associated allele results, when | ||
| used in conjunction with clinical findings and other laboratory tests, are | ||
| intended as an aid in the diagnosis of individuals with A1AT deficiency | ||
| (A1ATD). | ||
| The kit is indicated for prescription use only | ||
| Specimen Type | Same | Genomic DNA extracted from human whole blood samples collected |
| as DBS or in K2-EDTA and human saliva samples collected as buccal | ||
| swabs using ORAcollect-Dx model OCD-100. | ||
| Target | Same | Qualitative identification of A1AT alleles (which represent the |
| phenotypes) causing A1ATD. | ||
| Item | Candidate Device | Predicate Device |
| Modified A1AT Genotyping Test | A1AT Genotyping Test (K192858) | |
| Device | ||
| components | Same components, except for the CD component. A1AT | |
| Genotyping Test ANALYSIS SOFTWARE and instructions for use | ||
| are uploaded on a website. | The test is composed of four reagent components (A1AT PCR Master | |
| Mix, A1AT Beads Master Mix, SAPE and SAPE Dilution Buffer) in | ||
| sufficient quantity for either 48 or 192 tests and a CD containing the | ||
| A1AT Genotyping Test ANALYSIS SOFTWARE. | ||
| Technology | Same | Polymerase chain reaction (PCR) and hybridization-based in vitro |
| diagnostic test to be used with the Luminex 200™ instrument (with | ||
| xPONENT® software). |
DNA is extracted, amplified and biotinylated by multiplex PCR and
PCR products are denatured and hybridized to oligonucleotide probes
coupled to color coded beads. Hybridized DNA is labeled with a
fluorescent conjugate and resulting signal is detected with a Luminex®
200 system. The raw data obtained is finally processed with the A1AT
Genotyping Test ANALYSIS SOFTWARE in order to obtain the final
report. |
| Software
application | The software version has been updated (v1.0.8.16). Results of
every study have been re-analyzed with this updated software
version to ensure acceptance criteria are met. | A1AT Genotyping Test ANALYSIS SOFTWARE v1.0.6.1 |
| Item | Candidate Device | Predicate Device |
| | Modified A1AT Genotyping Test | A1AT Genotyping Test (K192858) |
| Product
Stability | Same | Real time stability: 24 months at 2-8°C
Open vial stability: 9 months at 2-8°C |
| Performance
specifications | - Lower Limit of Detection: 0.0215 ng/µl DNA. | - Lower Limit of Detection: 0.0310 ng/µl DNA. |
| | - Interferences: Same | Interferences: |
| | | • For blood samples: hemoglobin, bilirubin, triglycerides and
short blood draw. |
| | | • For saliva samples: α-amylase, hemoglobin,
immunoglobin A, total protein, microbes, eating food
without beef, eating food with beef, drinking, smoking,
chewing gum, mouth washing and brushing teeth. |
| | - Precision:
• Lot-to-Lot: 100% correct calls | Precision: |
| | • External reproducibility: Same | • Lot-to-Lot: overall correct call rate of 99.7% (one M/S sample
provided an incorrect result).
• External reproducibility: 100% correct calls. |
| | - Accuracy: Same | - Accuracy: 147 samples, comparator: Bi-directional Sanger
sequencing. |
| Intended
population | Same | Prescription use only |
| DNA extraction
method | Whole blood samples collected in K2-EDTA: same | Whole blood samples collected in K2-EDTA: QIAamp DNA Blood Mini
Kit (Qiagen)
Whole blood samples collected as DBS: |
| Item | Candidate Device
Modified A1AT Genotyping Test | Predicate Device
A1AT Genotyping Test (K192858) |
| | Whole blood samples collected as DBS: same, although the home-
made buffer will be removed. | – Commercial lysis and neutralization solutions (Sigma)
– Home-made buffer |
| | Saliva samples: same | Saliva samples:
– QIAamp DNA Blood Mini Kit (Qiagen)
– Commercial lysis and neutralization solutions (Sigma)
– QIAsymphony DNA Mini Kit (Qiagen) |
| Specimen
Stability | Same | – Whole blood samples collected in K2-EDTA: up to 24 days before DNA extraction at 2-8°C.
– Whole blood samples collected as DBS: up to 6 months at ambient temperature.
– Saliva samples collected as buccal swabs using ORAcollect-Dx model OCD-100 (DNA Genotek): up to 60 days when stored at ambient temperature. |
Comparison table:
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Progenika Biopharma GRIFOLS
Progenika Biopharma, S.A.
lbaizabal bidea, Edificio 504 Parque Tecnológico de Bizkaia
48160 Derio - Bizkaia - SPAIN
Phone: +34 94 406 45 25
Fax: +34 94 406 45 25
Fax: +34 94 406 45 26 ClF: ESA95091799
www.progenika.com - www.grifols.com
8
Progenika Biopharma GRIFOLS
Progenika Biopharma, S.A.
lbaizabal bidea, Edificio 504
Parque Tecnológico de Elizkaia
48160 Derio Bizkaia de Sizkaia
48160 Derio Bizkaia estis SPAIN
Fax: +34 94 406 45 25 ClF: ESA95091799
www.progenika.com - www.grifols.com
9
Progenika Biopharma GRIFOLS
Progenika Biopharma, S.A.
lbaizabal bidea, Edificio 504 Parque Tecnológico de Bizkaia
48160 Derio - Bizkaia - SPAIN
Phone: +34 94 406 45 25
Fax: +34 94 406 45 25
Fax: +34 94 406 45 26 ClF: ESA95091799
www.progenika.com - www.grifols.com
10
H. Performance Data:
Analytical Data:
- a) Precision/Reproducibility:
Lot-to-lot repeatability: The lot-to-lot repeatability was determined by testing the "Sample Panel" (five DNA samples covering Z/Z, M/Z, S/S, M/S, and S/Z Sample Results) in triplicate with three different reagent lots, by two operators, on six non-consecutive days, alternating between two Luminex instruments. An overall repeatability of 100% was obtained for Sample Results.
External Reproducibility: See K171868.
-
b) Reagent Stability:
See K171868 for initial Real-Time and Open-Vial Stabilities information and study designs and K192858 for final claimed stabilities of 24 months reagent stability when stored at 2-8ºC and up to 9 months reagent stability after the vials were first opened. -
c) Specimen Stability:
See K171868 for whole blood samples collected as DBS or in K2-EDTA stabilities.
See K152464 and K192858 for saliva samples stability collected in ORAcollect-Dx OCD-100.
- d) Lower Limit of Detection (LoD):
The DNA concentration at which 95% of sample replicates resulted in correct Sample Results was determined by testing 20 replicates of nine DNA dilutions of the "Sample Panel" (from 0.16 to 0.0033 ng/μl) using two reagent lots. It was shown that the highest LoD among the two lots used was 0.0215 ng/μl.
11
- e) DNA Extraction Variability:
See K171868 for DNA Extraction Variability in whole blood samples collected as DBS or in K2-EDTA information.
See K192858 for DNA Extraction Variability in saliva samples.
- f) Cross-reactivity and Cross-contamination: See K171868 for Cross-reactivity and Cross-contamination information.
- g) Interfering Substances:
See K171868 for Interfering Substances information in whole blood samples collected as DBS or in K2-EDTA.
See K192858 for Interfering Substances information in Saliva samples collected in ORAcollect-Dx OCD-100.
See K192858 for information about potentially interfering variants.
Comparison Data:
- h) Method Comparison:
See K171868 for Method Comparison information in whole blood samples. See K192858 for Method Comparison information in saliva samples.
Proposed Labeling: l.
The labeling is sufficient and it satisfies the requirements of 21 CFR 809.10.
J. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K. Date of summary preparation:
April 29, 2021