(29 days)
Not Found
No
The device description and performance studies describe a standard enzyme immunoassay and spectrophotometric analysis, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is an in vitro diagnostic (IVD) test for detecting benzodiazepines in human urine, not a device used for treatment or therapy.
Yes
The device is intended for the qualitative and/or semiquantitative determination of benzodiazepines and their metabolites in human urine, which is a diagnostic purpose. The text explicitly states it is for "In Vitro Diagnostic Use Only" and that "The Alinity c Benzodiazepines Reagent Kit is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid for indicating Benzodiazeoine abuse".
No
The device is a reagent kit used with an analyzer, which are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine". This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- "For In Vitro Diagnostic Use Only": The "Intended Use / Indications for Use" section concludes with the clear statement "For In Vitro Diagnostic Use Only." This is a standard labeling requirement for IVD devices.
- Device Description: The description details a laboratory-based assay using reagents to analyze a urine sample. This aligns with the definition of an in vitro diagnostic test.
- Intended User / Care Setting: The device is intended for use in "laboratories" by "trained professionals only", which is typical for IVD devices used in clinical or analytical settings.
N/A
Intended Use / Indications for Use
The Alinity o Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 umol/L) on the Alinity c analyzer.
The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only.
The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC- MS/MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
Product codes (comma separated list FDA assigned to the subject device)
JXM
Device Description
The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay with liquid ready to-use reagents. The assay uses a specific antibody that can detect most benzodiazepines and their metabolites in urine. The assay is based on competition between a drug labeled with glucose-6- phosphate dehydrogenase (G6PDH), and free sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the druq labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
Benzodiazepines are sedative-hypnotic drugs, which are subject to abuse. Benzodiazepines are include a wide variety of drugs such as alprazolam, diazepam, lorazepam, oxazepam, and triazolam. They are absorbed and metabolized at different rates, resulting in various psychoactive effects. Baselt describes the metabolism and toxicology of numerous benzodiazepines, including alprazeoam, chlordiazepoxide, clobazam, clorazepate, diazepan, estazolam, flunitrazepam, halazepam, medazepam, midazolam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, and triazolam.
The Alinity c Benzodiazepines Reagent Kit is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid for indicating Benzodiazeoine abuse through detection of benzodiazepines or their metabolites in urine
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories, trained professionals 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)
A. Accuracy and Method Comparison: CLSI Guideline: EP09-A3 and CLSI EP12-A2.
The Alinity c Benzodiazepines Reagent Kit demonstrated equivalent performance on the Alinity c analyzer when compared to the reference LC-MS/MS when using the qualitative and semiquantitative applications at a cutoff of 200 ng/mL. cutoff assay, the positive agreement was 100.00%, negative agreement was 96.96%, and overall agreement was 98.41% in both qualitative and semiquantitative applications.
B. Accuracy by Recovery and Dilution Linearity: CLSI Guideline: EP06-A
The Alinity c Benzodiazepines Reagent Kit underwent an Accuracy by Recovery and Dilution Linearity study to assess its dilution linearity and accuracy by recovery. The test mode used was semi- quantitative. A series of samples with expected concentrations ranging from 0.5 ng/mL to 1051.5 ng/mL were analyzed. The % recovery range for these samples was between 92.5% and 108.3%, indicating that the assay's accuracy by recovery was within the acceptable criteria of ± 20% from the expected concentration of each sample.
C. On-Board Reagent Stability: CLSI Guideline: EP25-A
The study was conducted to determine if sample results were susceptible to drift when the reagents were stored for 56 days for qualitative application and stored for a minimum of 7 days for semiquantitative application on board the Alinity c analyzer while the instrument was in continuous running mode. Reagent On-Board stability studies for one lot stored on-board clinical analyzer (Alinity c) supports the claim of 56 days for qualitative and semi-quantitative modes.
D. Precision: CLSI Guideline: EP05-A3
a. Within-Laboratory Precision Study
The Alinity c Benzodiazepines Reagent Kit demonstrated acceptable precision for both qualitative and semi-quantitative applications.
Greater than or equal to 95% of samples spiked at levels -25%, -50%, -75%, and -100% below the cutoffs read as negative and greater than or equal to 95% of samples spiked at levels +25%, +50%, +75%, +100% above the cutoffs read as positive in both Qualitative and Semi-quantitative modes.
b. Reproducibility Study
Alinity c Benzodiazepines Reagent Kit meets the acceptance criteria for precision (reproducibility) performance on multiple Alinity c clinical chemistry analyzers. In both qualitative and semiquantitative applications, 100% of samples at levels less than 200 ng/mL read as negative, and 100% of samples at levels higher than 200 ng/mL read as positive.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy and Method Comparison:
positive agreement was 100.00%
negative agreement was 96.96%
overall agreement was 98.41%
Accuracy by Recovery and Dilution Linearity:
% recovery range was between 92.5% and 108.3%
Precision:
Greater than or equal to 95% of samples spiked at levels -25%, -50%, -75%, and -100% below the cutoffs read as negative.
Greater than or equal to 95% of samples spiked at levels +25%, +50%, +75%, +100% above the cutoffs read as positive.
Reproducibility Study:
100% of samples at levels less than 200 ng/mL read as negative.
100% of samples at levels higher than 200 ng/mL read as positive.
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
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2024
Microgenics Corporation Nikhita Tandon Manager, Regulatory Affairs 46500 Kato Road Fremont, California 94538
Re: K243498
Trade/Device Name: Alinity c Benzodiazepines Reagent Kit Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine Test System Regulatory Class: Class II Product Code: JXM Dated: November 11, 2024 Received: November 12, 2024
Dear Nikhita Tandon:
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.
1
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 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/postmarketing-safetyreporting-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
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,
Image /page/2/Picture/3 description: The image shows the name "Joseph A. Kotarek -S" and a digital signature. The digital signature states that it was signed by Joseph A. Kotarek -S on December 11, 2024, at 14:38:36. The time zone is -05'00'. The name is written in a larger font than the digital signature.
Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K243498
Device Name Alinity c Benzodiazepines Reagent Kit
Indications for Use (Describe)
The Alinity o Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 umol/L) on the Alinity c analyzer.
The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only.
The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC- MS/MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid
Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
| 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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Alinity c Benzodiazepines Reagent Kit Special Premarket Notification
510(k) Summary K243498
I. Device Information
| Contact Details | |
|---|---|
| Sponsor: | Microgenics Corporation |
| Thermo Fisher Scientific | |
| 46500 Kato Road | |
| Fremont, CA 94538, USA | |
| Phone: 925-208-7045 | |
| Correspondent Contact Information: | Nikhita Tandon |
| Manager, Regulatory Affairs | |
| Email: Nikhita.tandon@thermofisher.com | |
| Phone:925-208-7045 | |
| Device Name | |
| Device Trade Name: | Alinity c Benzodiazepines Reagent Kit |
| Common Name: | Benzodiazepine Test System |
| Classification Name: | Enzyme Immunoassay, Benzodiazepine |
| Regulation Number: | 21 CFR 862.3170 |
| Product Code: | JXM |
| Legally Marketed Predicate Device | |
| Predicate Premarket Notification Number: | K173963 |
| Predicate Trade Name: | DRI Benzodiazepine Assay |
| Predicate Common Name: | Benzodiazepine Test System |
| Predicate Classification Name: | Enzyme Immunoassay, Benzodiazepine |
| Predicate Regulation Number: | 21 CFR 862.3170 |
| Predicate Product Code: | JXM |
ll. Date Summary Prepared
November 11, 2024
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lll. Description of Device
The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay with liquid ready to-use reagents. The assay uses a specific antibody that can detect most benzodiazepines and their metabolites in urine. The assay is based on competition between a drug labeled with glucose-6- phosphate dehydrogenase (G6PDH), and free sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the druq labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
Benzodiazepines are sedative-hypnotic drugs, which are subject to abuse. Benzodiazepines are include a wide variety of drugs such as alprazolam, diazepam, lorazepam, oxazepam, and triazolam. They are absorbed and metabolized at different rates, resulting in various psychoactive effects. Baselt describes the metabolism and toxicology of numerous benzodiazepines, including alprazeoam, chlordiazepoxide, clobazam, clorazepate, diazepan, estazolam, flunitrazepam, halazepam, medazepam, midazolam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, and triazolam.
The Alinity c Benzodiazepines Reagent Kit is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid for indicating Benzodiazeoine abuse through detection of benzodiazepines or their metabolites in urine
IV. Intended Use
- A. Indications for Use:
See indications for use below.
B. Intended Use:
The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 umol/L) on the Alinity c analyzer.
The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only. The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC- MS/MS) or permitting laboratories to establish quality control
6
procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method : 2 Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
V. Comparison to Predicate Device
| Characteristics | Predicate Device
DRI Benzodiazepine Assay (K173963) | Candidate Device
Alinity c Benzodiazepines Reagent Kit | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | See intended use below for indications use | See intended use below for indications use | Identical |
| Intended Use | The DRI® Benzodiazepine Assay is a
homogeneous enzyme immunoassay
intended for the qualitative and/or semi-
quantitative determination of the presence of
benzodiazepines and their metabolites in
human urine at a cutoff concentration of 200
ng/mL. The assay is intended to be used in
laboratories and provides a rapid analytical
screening procedure to detect
benzodiazepines in human urine. The assay
is designed for use with a number of clinical
chemistry analyzers. This assay is calibrated
against Oxazepam. This product is intended
to be used by trained professionals only.
The semi-quantitative mode is for the purpose
of enabling laboratories to determine an
appropriate dilution of the specimen for
confirmation by a confirmatory method such
as Liquid Chromatography/tandem mass | The Alinity c Benzodiazepines Reagent Kit is a
homogeneous enzyme immunoassay intended
for the qualitative and/or semiquantitative
determination of the presence of
benzodiazepines and their metabolites in
human urine at a cutoff concentration of 200
ng/mL (0.700 µmol/L) on the Alinity c analyzer.
The assay is intended to be used in
laboratories and provides a rapid analytical
screening procedure to detect
benzodiazepines in human urine. This assay is
calibrated against oxazepam. This product is
intended to be used by trained professionals
only.
The semi-quantitative mode is for the purpose
of enabling laboratories to determine an
appropriate dilution of the specimen for
confirmation by a confirmatory method such as
Liquid Chromatography/Tandem Mass | Identical with exception to the
brand name of the device and
naming of the clinical
chemistry analyzer. This does
not impact the intended use of
device. |
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| | Predicate Device
Characteristics DRI Benzodiazepine Assay (K173963) | Candidate Device
Alinity c Benzodiazepines Reagent Kit | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | spectrometry (LC-MS/MS) or permitting
laboratories to establish quality control
procedures.
The assay provides only a preliminary
analytical test result. A more specific
alternative chemical method must be used to
obtain a confirmed analytical result. Gas
chromatography/ mass spectrometry
(GC/MS) or Liquid chromatography/tandem
mass spectrometry (LC-MS/MS) is the
preferred confirmatory method.
Clinical and professional judgment should be
applied to any drug of abuse test result,
particularly when preliminary results are used.
For In Vitro Diagnostic Use Only. | Spectrometry (LC-MS/MS) or permitting
laboratories to establish quality control
procedures.
The assay provides only a preliminary
analytical test result. A more specific
alternative chemical method must be used to
obtain a confirmed analytical result. Gas
Chromatography/Mass Spectrometry (GC/MS)
or Liquid Chromatography/Tandem Mass
Spectrometry
(LC-MS/MS) is the preferred confirmatory
method.
Clinical and professional judgment should be
applied to any drug of abuse test result,
particularly when preliminary results are used.
For In Vitro Diagnostic Use Only. | |
| FDA Product
Code | JXM | JXM | Identical |
| Device
Classification
and Name | 21 CFR 862.3170, ENZYME
IMMUNOASSAY, BENZODIAZEPINE
Benzodiazepine test system, 91 - Toxicology | 21 CFR 862.3170, ENZYME IMMUNOASSAY,
BENZODIAZEPINE
Benzodiazepine test system, 91 - Toxicology | Identical |
| Operating
Principle
(Technology) | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay | Identical |
| | Predicate Device | Candidate Device | |
| Characteristics | DRI Benzodiazepine Enzyme Immunoassay
(K173963) | Alinity c Benzodiazepines Reagent Kit | Comparison |
| Analyte | Benzodiazepines | Benzodiazepines | Identical |
| Measured Analyte | Benzodiazepines and their metabolites | Benzodiazepines and their metabolites | Identical |
| Test Matrix | Human Urine | Human Urine | Identical |
| Cut-off Levels | 200 ng/mL | 200 ng/mL | Identical |
| Methodology | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay | Identical |
| Materials | Antibody/Substrate Reagent contains
active ingredients: sheep polyclonal anti-
benzodiazepine antibodies, glucose-6-
phosphate (G6P) and nicotinamide adenine
dinucleotide (NAD) and Inactive ingredients:
TRIS buffer, bovine serum albumin (BSA).
Preservative: sodium azide | Antibody/Substrate Reagent contains
active ingredients: Anti-benzodiazepine sheep
polyclonal antibodies, glucose-6-phosphate
(G6P) and nicotinamide adenine dinucleotide
(NAD) and Inactive ingredients: TRIS buffer,
bovine serum albumin (BSA). Preservative:
sodium azide | Identical |
| | Enzyme Conjugate Reagent contains active
ingredients: benzodiazepine derivative labeled
with glucose-6-phosphate dehydrogenase
(G6PDH) and Inactive ingredients: TRIS
buffer, BSA. Preservative: sodium azide | Enzyme Conjugate Reagent contains active
ingredients: benzodiazepine derivative labeled
with glucose-6-phosphate dehydrogenase
(G6PDH) and Inactive ingredients: TRIS buffer,
BSA. Preservative: sodium azide | |
| Reagent Form | Liquid ready-to-use
Reagents are sold in three sizes, 18 mL, 100
mL and 500 mL kits. | Liquid ready-to-use
Reagents are sold as 2 cartridges per kit with
250 tests per cartridge and 500 tests per kit
Volume of R1 per cartridge: 32.2 mL
Volume of R2 per cartridge: 31.8 mL | Identical Formulation. Kit
available in different sizes |
| Antibody | Sheep Polyclonal Anti-benzodiazepine
antibodies | Sheep Polyclonal Anti-benzodiazepine
antibodies | Identical |
| Storage | 2-8°C until expiration date | 2-8°C until expiration date | Identical |
| Principal Operator | Trained professionals | Trained professionals | Identical |
| Instrument | Beckman Coulter AU680 Clinical Chemistry
Analyzer | Alinity c Analyzer System | Different analyzers, but both
meet the following
requirements: Automated
clinical analyzers capable of
maintaining a constant
temperature, pipetting, mixing
reagents, measuring
enzymatic rates at 340 nm and
timing the reaction accurately. |
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Image /page/10/Picture/1 description: The image displays the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, with "Scientific" in black underneath. The font is bold and sans-serif, giving the logo a modern and corporate appearance. The logo is simple and recognizable.
| Characteristics | Predicate Device
DRI Benzodiazepine Enzyme Immunoassay
(K173963) | Candidate Device
Alinity c Benzodiazepines Reagent Kit | Comparison |
|-----------------|------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Package Insert | Header and footer | Header and footer | Different, candidate device's
header and footer has been
modernized to reflect present
labeling regulation and
practices and branding |
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| Characteristics | Predicate Device
DRI Benzodiazepine Enzyme Immunoassay
(K173963) | Candidate Device
Alinity c Benzodiazepines Reagent Kit | Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additional Material | Additional Material | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Ref Kit Description 1664 DRI Negative Calibrator, 10 mL 1388 DRI Negative Calibrator, 25 mL 1588 DRI Multi-Drug Urine Calibrator 1, 10 mL 1589 DRI Multi-Drug Urine Calibrator 1, 25 mL 1591 DRI Multi-Drug Urine Calibrator 2, 10 mL 1592 DRI Multi-Drug Urine Calibrator 2, 25 mL 1594 DRI Multi-Drug Urine Calibrator 3, 10 mL 1595 DRI Multi-Drug Urine Calibrator 3, 25 mL 1597 DRI Multi-Drug Urine Calibrator 4, 10 mL 1598 DRI Multi-Drug Urine Calibrator 4, 25 mL DOAT-4 MAS® DOA Total-Level 4 DOAT-5 MAS® DOA Total-Level 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | Ref Kit Description 08P6306 Alinity c DOA MC Negative
Calibrator Kit 09P5201 Alinity c Benzodiazepines Qual
Calibrator Kit 09P5202 Alinity c Benzodiazepines
Semiquant Calibrator Kit 08P6318 Alinity c DOA MC I Controls | | | | | | | | | | | Calibrators and Controls are
Identical in formulation but
assigned different Ref.
numbers.
DOA MC Cals/controls contain
Oxazepam and are traceable
to the Oxazepam drug
purchased from a commercial
source which is established at
98% purity. |
12
Alinity c Benzodiazepines Reagent Kit Special Premarket Notification
| Characteristics | Predicate Device | Candidate Device | Comparison |
|---|---|---|---|
| DRI Benzodiazepine Enzyme Immunoassay | |||
| (K173963) | Alinity c Benzodiazepines Reagent Kit | ||
| Precautions and Warnings | Precautions and Warnings | Different, candidate device | |
| precautions and warnings have | |||
| been modernized to reflect | |||
| present safety regulations. | |||
| The reagents are harmful if swallowed. | |||
| • [IVD] | |||
| DANGER: | • For In Vitro Diagnostic Use | ||
| 1. The reagents contain ≤ 0.2% bovine serum | |||
| albumin (BSA) and ≤0.5% Drug-specific | • [Rx Only] | ||
| Safety Precautions | |||
| antibody (Sheep). Avoid contact with skin and | CAUTION: This product requires the handling | ||
| mucous membranes. Avoid inhalation. | |||
| May cause skin or inhaled allergic reaction. | of human specimens. It is recommended that | ||
| all human-sourced materials and all | |||
| 2. In the case of accidental spill, clean and | consumables contaminated with potentially | ||
| dispose of material according to your | infectious materials be considered potentially | ||
| laboratory's Standard Operating Procedure, | infectious and handled in accordance with the | ||
| local, and state regulations. | OSHA Standard on Bloodborne Pathogens. | ||
| 3. In the case of damaged packaging on | Biosafety Level 2 or other appropriate regional, | ||
| arrival, contact your technical support | national, and institutional biosafety practices | ||
| representative. | should be used for materials that contain, are | ||
| 4. Reagents used in the assay components | suspected of containing, or are contaminated | ||
| contain ≤0.09% sodium azide. Avoid contact | with infectious agents.5-8 | ||
| with skin and mucous membranes. Refer to | |||
| Safety Data Sheet for additional precautions, | |||
| handling instructions, and accidental exposure | The following warnings and precautions | ||
| treatment. | apply to: [R1] | ||
| H317 - May cause allergic skin reaction. | Contains sodium azide. | ||
| H334 - May cause allergy or asthma | EUH032 Contact with acids liberates very | ||
| symptoms or breathing difficulties if inhaled. | toxic gas. | ||
| Avoid breathing mist or vapor. Contaminated | P501 Dispose of contents / container in | ||
| accordance with local regulations. | |||
| work clothing should not be allowed out of the | |||
| workplace. Wear protective gloves/eye | |||
| protection/face protection. In case of | The following warnings and precautions apply | ||
| inadequate | to: [R2] | ||
| Characteristics | Predicate Device | Candidate Device | Comparison |
| DRI Benzodiazepine Enzyme Immunoassay | |||
| (K173963) | Alinity c Benzodiazepines Reagent Kit | ||
| ventilation wear respiratory protection. If on | |||
| skin: Wash with plenty of soap and water. IF | |||
| NHALED: If breathing becomes difficult, | |||
| remove victim to fresh air and keep at rest in a | |||
| position | |||
| comfortable for breathing. If skin irritation or | |||
| rash occurs: Get medical advice/attention. If | |||
| experiencing respiratory symptoms: Call a | |||
| POISON CENTER or doctor/physician. Wash | |||
| contaminated clothing before reuse. Dispose | |||
| of contents/container to location in accordance | |||
| with local/regional/national/international | |||
| regulations. | WARNING Contains tromethamine | ||
| hydrochloride* and sodium azide. | |||
| H316* Causes mild skin irritation. | |||
| EUH032 Contact with acids liberates very | |||
| toxic gas. |
Response
P332+P313* If skin irritation occurs: Get medical
advice / attention.
Disposal
P501 Dispose of contents / container in
accordance with local regulations.
- Not applicable where regulation EC
1272/2008 (CLP) or OSHA Hazard
Communication 29 CFR 1910.1200 (HCS)
2012
have been implemented.
Follow local chemical disposal regulations
based on your location along with
recommendations and content in the
Safety Data Sheet to determine the safe
disposal of this product.
For the most current hazard information, see
the product Safety Data Sheet.
Safety Data Sheets are available at
www.corelaboratory.abbott or contact your
local representative | |
13
14
| ThermoFisher | |||||
|---|---|---|---|---|---|
| S C I E N T I F I C |
| Predicate Device | Candidate Device | ||||||
|---|---|---|---|---|---|---|---|
| Characteristics | DRI Benzodiazepine Enzyme Immunoassay | ||||||
| (K173963) | Alinity c Benzodiazepines Reagent Kit | Comparison | |||||
| Specimen Collection and Preparation | Specimen Collection and Preparation | Different, candidate device specimen collection and preparation has been modernized to reflect present guidelines and provide clearer handling instructions. | |||||
| Collect urine specimens in plastic or glass containers. Care should be taken to preserve the chemical integrity of the urine sample from the time it is collected until the time it is assayed. | The specimen type used for this assay is human urine only. | ||||||
| The specimen type listed below was verified for use with this assay. | |||||||
| Specimens kept at room temperature that do not receive initial test within 7 days5 of arrival at the laboratory may be placed into a secure refrigeration unit at 2-8°C for two months.6 For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20°C.6, 7 | Specimen Collection Vessel Special | ||||||
| Type Conditions Urine Clean plastic or glass container | |||||||
| Testing of fresh urine specimens is suggested. Samples within a pH range of 3 to 11 are suitable for testing with this assay. | |||||||
| Laboratories following the SAMHSA mandatory guidelines should refer to SAMHSA “Short- Term Refrigerated Storage” and “Long-Term Storage” requirements.4 | The instrument does not provide the capability to verify specimen types. It is the responsibility of the operator to verify that the correct specimen types are used in the assay. Specimen Conditions Analyze fresh specimens if possible. To prevent cross contamination, use of disposable pipettes or pipette tips is recommended. Preparation for Analysis | ||||||
| To protect the integrity of the sample, do not induce foaming and avoid repeated freezing and thawing. An effort should be made to keep pipetted samples free of gross debris. It is recommended that grossly turbid specimens be centrifuged before analysis. Frozen samples should be thawed and mixed prior to analysis. Adulteration of the urine sample may cause erroneous results. If adulteration is |
15
| Characteristics | Predicate Device | Candidate Device | Comparison |
|---|---|---|---|
| DRI Benzodiazepine Enzyme Immunoassay | |||
| (K173963) | Alinity c Benzodiazepines Reagent Kit | ||
| suspected, obtain another sample and forward | |||
| both specimens to the laboratory for testing. | Adulteration of the urine specimen may cause | ||
| erroneous results. If adulteration is suspected, | |||
| obtain another specimen and forward both | |||
| specimens to the laboratory for testing. | |||
| Handle all urine specimens as if they were | |||
| potentially infectious. | An effort should be made to keep pipetted | ||
| specimens free of gross debris. It is recommended | |||
| that highly turbid | |||
| specimens be centrifuged before analysis. | |||
| Stored specimens must be inspected for | |||
| particulates. If present, mix with a low speed vortex | |||
| or by inversion and | |||
| centrifuge the specimen to remove particulates | |||
| prior to testing. | |||
| Prepare frozen specimens as follows: | |||
| • Frozen specimens must be completely | |||
| thawed before mixing. | |||
| • Mix thawed specimens thoroughly. | |||
| • Visually inspect the specimens. If layering or | |||
| stratification is observed, mix until specimens | |||
| are visibly homogeneous. | |||
| • If specimens are not mixed thoroughly, | |||
| inconsistent results may be obtained. | |||
| Specimen Storage | |||
| Analyze fresh specimens if possible. | |||
| Specimen | |||
| Type | |||
| Temperature | Maximum Storage Tim | ||
| Characteristics | Predicate Device | Candidate Device | Comparison |
| DRI Benzodiazepine Enzyme Immunoassay | |||
| (K173963) | Alinity c Benzodiazepines Reagent Kit | ||
| Urine | |||
| Room Temperature | |||
| 2 to 8°C | |||
| 24 hours9 | |||
| 30 days10 | |||
| If analysis will not be completed within the maximum storage recommendations, the urine should be frozen at or below -20°C.11 Repeated freeze/thaw cycles should be avoided to minimize analyte deterioration. | |||
| It is the responsibility of the individual laboratory to determine specific specimen stability criteria for their laboratory per their laboratory workflow. | |||
| For additional information on sample handling and processing, refer to CLSI C52-ED3.11 The storage information provided here is based on references maintained by the manufacturer. | |||
| Stored specimens must be inspected for particulates. If present, mix with a low-speed vortex or by inversion and centrifuge the specimen to remove particulates prior to testing. | |||
| Specimen Shipping | |||
| Package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. | |||
| Characteristics | Predicate Device | ||
| DRI Benzodiazepine Enzyme Immunoassay | |||
| (K173963) | Candidate Device | ||
| Alinity c Benzodiazepines Reagent Kit | Comparison | ||
| Do not exceed the storage limitations listed above. | |||
16
17
18
| ThermoFisher | ||||
|---|---|---|---|---|
| S C I E N T I F I C |
| Predicate Device | Candidate Device | ||
|---|---|---|---|
| Characteristics | DRI Benzodiazepine Enzyme Immunoassay | Alinity c Benzodiazepines Reagent Kit | Comparison |
| (K173963) | |||
| References |
- Department of Health and Human Services.
Notice of Mandatory Guidelines For Federal
Workplace Drug Testing Programs: Final
guidelines. Federal Register, Substance
Abuse and Mental Health Administration
(SAMHSA), (1994) 110 (June 9): 11983. - Zaitsu K, Miki A, Katagi M, Tsuchihashi H.
Long-term stability of various drugs and
metabolites in urine, and preventive measures
against their decomposition with special
attention to filtration sterilization. Forensic
Science Intl 174 (2008) 189-196. - Gonzales E, Ng G, Pesce A, West C, West R, Mikel C, Llaatyshev, S, Almazan P. Stability
of pain-realted medications, metabolites and
illicit substances in urine. Clinica Chimca Acta
416: (2013) 30-35. - C52-A2, Toxicology and Drug Testing in the
Clinical Laboratory; Approved Guideline –
Second Edition, Clinical and Laboratory
Standards Institute (CLSI) (April 2007). | References - Dahlin JL, Palte MJ, LaMacchia J, Petrides
AK. A Rapid Dilute-and-Shoot UPLC-MS/MS
Assay to Simultaneously Measure 37 Drugs
and Related Metabolites in Human Urine for
Use in Clinical Pain Management. J Appl Lab
Med 2019;3(6):974-992. - Dixon RB, Mbeunkui F, Wiegel JV. Stability
study of opioids and benzodiazepines in urine
samples by liquid chromatography tandem
mass spectrometry. J Anal Sci Technol 2015;
6(17). - Clinical and Laboratory Standards Institute
(CLSI). Toxicology and Drug Testing in the
Medical Laboratory; Approved Guideline–
Third Edition. CLSI Document C52. Wayne,
PA: CLSI; 2017. | Different, candidate device
lists citations/references
modernized to represent
accurate and present
guidelines. |
| Characteristics | Predicate Device
DRI Benzodiazepine
Enzyme
Immunoassay
(K173963) | Candidate Device
Alinity c Benzodiazepines Reagent
Kit | Comparison |
| Performance
Characteristics | **Data on the IFU is representative. Actual values collected on the 2 devices à Predicate
Device (Beckman Coulter AU680 Clinical Chemistry Analyzer) and on the Candidate Device
(Alinity c Analyzer System), are not expected to be identical as they have been collected on
different instruments, with different lots of reagents and samples.
As demonstrated below, the results on both devices are proven to be substantially equivalent. | | |
| Characteristics | Predicate Device
DRI Benzodiazepine
Enzyme
Immunoassay
(K173963) | Candidate Device
Alinity c Benzodiazepines Reagent
Kit | |
| | Precision (Within-
Laboratory Precision) | Precision (Within-Laboratory
Precision and Reproducibility) | Predicate Device and Candidate
Device performance data are
substantially equivalent in
demonstrating precision (Within-
Laboratory Precision)
Additional reproducibility data is
added to reflect the present
guideline. |
| | | | For Within-Laboratory Precision
≥95% of samples spiked at levels -
25%, -50%, -75%, and -100% below
the 200 ng/mL cutoff read as
negative and ≥95% of samples
spiked at levels +25%, +50%,
+75%, +100% above the 200 ng/mL
cutoff read as positive in both
qualitative and semi-quantitative
modes. |
| | | | For Reproducibility
In both qualitative and
semiquantitative applications, 100%
of samples at levels less than 200
ng/mL read as negative, and 100%
of samples at levels higher than 200
ng/mL read as positive.
Alinity c Benzodiazepines Reagent
Kit meets the acceptance criteria for
precision (reproducibility)
performance on multiple Alinity c |
| Characteristics | Predicate Device
DRI Benzodiazepine
Enzyme
Immunoassay
(K173963) | Candidate Device
Alinity c Benzodiazepines Reagent
Kit | Comparison |
| | Accuracy and Method
comparison | Accuracy and Method Comparison | Predicate Device and Candidate
Device are substantially equivalent
in demonstrating Accuracy when the
immunoassay method (predicate
device or candidate device at 200
ng/mL cutoff) is compared to the
reference confirmatory method LC-
MS/MS in measuring patient
samples. Both devices showed
≥90% negative sample, positive
sample and overall percent
agreement with LC-MS/MS. |
| | Accuracy by
Recovery and Dilution
Linearity | Accuracy by Recovery and Dilution
Linearity | Predicate Device and Candidate
Device are substantially equivalent
in demonstrating dilution linearity
throughout the calibration range.
For both devices. the %Recovery of
Mean Observed Concentration in
relative to Expected (Target)
Concentration for each sample met
acceptance criterion (± 20% from
the expected concentration). |
| | Onboard Stability -
N/A because the
device is designed for
use with a number of
clinical
chemistry analyzers. | Onboard stability- 56 days, because
the device is designed for use on
specific clinical chemistry analyzer-
the Alinity platform | Candidate Device achieved on-
board reagent stability of 56 days. |
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Image /page/19/Picture/1 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, and the word "SCIENTIFIC" is in black. The logo is simple and modern.
20
Image /page/20/Picture/1 description: The image contains the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, bold font on the top line. The word "SCIENTIFIC" is in a smaller, black, bold font on the second line.
21
Image /page/21/Picture/1 description: The image contains the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, stacked on top of the word "SCIENTIFIC" which is in black. The logo is simple and modern.
| Characteristics | Predicate Device
DRI Benzodiazepine Enzyme
Immunoassay (K173963) | Candidate Device
Alinity c Benzodiazepines
Reagent Kit | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Specimen storage and
stability | Specimen storage and stability | Compared to Predicate Device,
Specimen storage and stability has
been modernized in the Candidate
Device to reflect accurate present
guidelines and provide clearer
handling instructions for specimen
storage and stability claim when
compared to the predicate device.
Refer to the specimen collection and
preparation comparison under
"package insert" section above for
supporting literature references. |
| | Specificity (cross
reactivity -
structurally related
and unrelated) Interference Specific Gravity Shelf-life Stability Traceability | Specificity (cross
reactivity - structurally
related and unrelated) Interference Specific Gravity Shelf-life Stability Traceability | Identical, as these performance
studies are not instrument dependent |
| Product
Labeling | Kit Labeling Component
Labeling | Kit Labeling Component
Labeling | Different, candidate device kit and
component labeling have been
modernized to reflect present the
current labeling regulation, safety
practices and branding. |
VI. Summary of Performance Testing
A. Accuracy and Method Comparison: CLSI Guideline: EP09-A3 and CLSI EP12-A2.
The Alinity c Benzodiazepines Reagent Kit demonstrated equivalent performance on the Alinity c analyzer when compared to the reference LC-MS/MS when using the qualitative and semiquantitative applications at a cutoff of 200 ng/mL. cutoff assay, the positive agreement was 100.00%, negative agreement was 96.96%, and overall agreement was 98.41% in both qualitative and semiquantitative applications.
22
B. Accuracy by Recovery and Dilution Linearity: CLSI Guideline: EP06-A
The Alinity c Benzodiazepines Reagent Kit underwent an Accuracy by Recovery and Dilution Linearity study to assess its dilution linearity and accuracy by recovery. The test mode used was semi- quantitative. A series of samples with expected concentrations ranging from 0.5 ng/mL to 1051.5 ng/mL were analyzed. The % recovery range for these samples was between 92.5% and 108.3%, indicating that the assay's accuracy by recovery was within the acceptable criteria of ± 20% from the expected concentration of each sample.
C. On-Board Reagent Stability: CLSI Guideline: EP25-A
The study was conducted to determine if sample results were susceptible to drift when the reagents were stored for 56 days for qualitative application and stored for a minimum of 7 days for semiquantitative application on board the Alinity c analyzer while the instrument was in continuous running mode. Reagent On-Board stability studies for one lot stored on-board clinical analyzer (Alinity c) supports the claim of 56 days for qualitative and semi-quantitative modes.
D. Precision: CLSI Guideline: EP05-A3
a. Within-Laboratory Precision Study
The Alinity c Benzodiazepines Reagent Kit demonstrated acceptable precision for both qualitative and semi-quantitative applications.
Greater than or equal to 95% of samples spiked at levels -25%, -50%, -75%, and -100% below the cutoffs read as negative and greater than or equal to 95% of samples spiked at levels +25%, +50%, +75%, +100% above the cutoffs read as positive in both Qualitative and Semi-quantitative modes.
b. Reproducibility Study
Alinity c Benzodiazepines Reagent Kit meets the acceptance criteria for precision (reproducibility) performance on multiple Alinity c clinical chemistry analyzers. In both qualitative and semiquantitative applications, 100% of samples at levels less than 200 ng/mL read as negative, and 100% of samples at levels higher than 200 ng/mL read as positive.
VII. Conclusion
The information supports a determination of substantial equivalence between the candidate device Alinity c Benzodiazepines Reagent Kit and the predicate device DRI Benzodiazepine Assay (K173963).