(173 days)
Not Found
No
The description details a homogeneous enzyme immunoassay based on recombinant DNA technology and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) assay designed to detect the presence of a heroin metabolite in human urine, not to treat or cure a disease or condition.
Yes
The device is described as an "in vitro qualitative and or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine," and its purpose is to provide "a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine." This directly aligns with the definition of a diagnostic device, which is used to identify or detect a particular condition or substance. The statement "The assay provides only a preliminary analytical test result" also confirms its diagnostic nature, indicating it's an initial step in identifying drug presence.
No
The device is described as a "homogeneous enzyme immunoassay" and is supplied as a "two liquid and two lyophilized reagent kit." This clearly indicates the device includes physical reagents and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only."
- Intended Use: The device is intended for the "in vitro qualitative and or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine." This involves testing a sample taken from the human body outside of the body.
- Sample Type: The assay is performed on "human urine," which is a biological specimen.
- Purpose: The assay provides a "rapid analytical screening procedure to detect 6-Acetylmorphine in human urine," which is a diagnostic purpose.
- Care Setting: The assay is intended to be used in "laboratories," a typical setting for IVD testing.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIATM Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. 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 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 with 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)
DJG
Device Description
CEDIA technology uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzymes that, in the assay format, cleave a substrate. This generates a color change that can be measured spectrophotometrically.
CEDIA™ Heroin Metabolite (6-AM) Assay is supplied as a two liquid and two lyophilized reagent kit homogeneous enzyme immunoassay. The assay uses an antibody that is specific for 6-Acetylmorphine and cross reacts with Heroin. The assay has minimal cross reactivity to structurally related and unrelated compounds. In the assay, analyte in the sample competes with analyte coniugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjuqated on the inactive fragment, inhibiting the reassociation of inactive ß- galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
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
trained professionals / laboratories
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:
For Qualitative and semi-quantitative mode. ≥ 95% of samples below the cutoff read as neqative and ≥ 95% of samples above the cutoff read as positive.
Spike Recovery:
In qualitative mode, there is no ± 2SD overlap between the spiked 10 ng/mL, 7.5 and 12.5 ng/mL samples. All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples are detected as Negative and Positive, respectively, when compared to 10 ng/mL spiked sample.
In semi-quantitative mode, the spiked samples recover within 80–120% of the nominal values.
Dilution Linearity:
The assay demonstrates linearity throughout the calibration range of 0 to 20 ng/mL and R > 0.99. The mean recovery at each level is within 80-120% of expected values.
Method Comparison:
The negative agreement in qualitative mode is 100% and semi-quantitative mode is 98.4%. The positive agreement in qualitative mode is 100% and Semi-quantitative mode is 98.3%. The overall correlation agreement in Qualitative mode is 100% and Semi-quantitative mode is 98.4%.
Specificity:
Cross-Reactivity - The assay is specific for 6-Acetylmorphine and demonstrates cross-reactivity to heroin. Minimal cross-reactivity is observed with other structurally related and unrelated compounds.
Interference - Results demonstrate that there is no significant interference from the endogenous and exogenous substances in human urine at the tested concentrations, in samples within pH range of 3-11 and in samples with specific gravity within 1.000-1.030.
Stability:
Reagent On-Board Stability - Reagent On-Board stability studies for one lot stored on-board clinical analyzer supports the claim of 60 days for qualitative and semi-quantitative modes.
Reconstituted Reagent Stability - Reconstituted Reagent stability studies for one lot stored at 2-8°C supports the claim of 60 days for qualitative and semi-quantitative modes.
Open Vial Stability - Open Vial stability studies for one lot stored at 2-8°C supports the claim of 60 days for qualitative and semi-quantitative modes. This data was presented in the original 510(k) submission K192943.
Real Time Stability for Reagent - Real time stability studies for three lots of reagents stored at 2–8°C have been carried out for up to 26 months. Proposed shelf-life claim is 24 months. This data was presented in the 510(k) submission K192943.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Negative agreement in qualitative mode is 100%
Semi-quantitative mode negative agreement is 98.4%
Positive agreement in qualitative mode is 100%
Semi-quantitative mode positive agreement is 98.3%
Overall correlation agreement in Qualitative mode is 100%
Overall correlation agreement in Semi-quantitative mode is 98.4%
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
Microgenics Corporation Amrit Takhar Regulatory Affairs Specialist II 46500 Kato Road Fremont, California 94538
Re: K231007
Trade/Device Name: CEDIA"M Heroin Metabolite (6-AM) Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: August 11, 2023 Received: August 15, 2023
Dear Amrit Takhar:
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 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 requirements,
1
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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-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,
Joseph A. Kotarek -S
Digitally signed by Joseph A. Kotarek -S Date: 2023.09.27 17:25:56 -04'00'
Joseph Kotarek Toxicology 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
2
Indications for Use
510(k) Number (if known) K231007
Device Name CEDIATM Heroin Metabolite (6-AM) Assay
Indications for Use (Describe)
The CEDIATM Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. 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 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 with 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) | ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510K Summary K231007
Device Information l.
| Contact Details | |
|---|---|
| Sponsor: | Microgenics Corporation Thermo Fisher |
| Scientific 46500 Kato Road | |
| Fremont, CA 94538 | |
| Phone: 510-979-5000 | |
| FAX: 510-979-5002 | |
| Correspondent Contact Information: | Amrit Takhar |
| Regulatory Affairs Specialist II, | |
| Regulatory Affairs | |
| Email: Amrit.Takhar@thermofisher.com | |
| Phone: 510-979-5000 | |
| FAX: 510-979-5002 | |
| Device Name | |
| Device Trade Name: | CEDIA™ Heroin Metabolite (6-AM) Assay |
| Common Name: | Opiate Test System |
| Classification Name: | Enzyme Immunoassay, Opiates |
| Regulation Number: | 862.3650 |
| Product Code: | DJG |
| Legally Marketed Predicate Device | |
| Predicate Premarket Notification Number: | K192943 |
| Predicate Trade Name: | CEDIA™ Heroin Metabolite (6-AM) Assay |
| Predicate Common Name: | Opiate Test System |
| Predicate Classification Name: | Enzyme Immunoassay, Opiates |
| Predicate Regulation Number: | 862.3650 |
| Predicate Product Code: | DJG |
ll. Date Summary Prepared
September 27, 2023
lll. Description of Device
CEDIA technology uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzymes that, in the assay format, cleave a substrate. This generates a color change that can be measured spectrophotometrically.
CEDIA™ Heroin Metabolite (6-AM) Assay is supplied as a two liquid and two lyophilized reagent kit homogeneous enzyme immunoassay. The assay uses an antibody that is specific for 6-Acetylmorphine and cross reacts with Heroin. The assay has minimal cross
4
reactivity to structurally related and unrelated compounds. In the assay, analyte in the sample competes with analyte coniugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the
inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjuqated on the inactive fragment, inhibiting the reassociation of inactive ß- galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
IV. Intended Use
A. Indications for Use:
See indications for use below.
B. Intended Use:
The CEDIA™ Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. 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 Liguid 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 with 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.
Candidate Device Predicate Device CEDIA™ Heroin Characteristics CEDIA™ Heroin Comparison Metabolite (6-AM) Assay Metabolite (6-AM) Assay (K192943) See intended use below for See intended use below for Indications for Identical Use indications use indications use
V. Comparison to Predicate Device
5
| Characteristics | Candidate Device
CEDIATM Heroin
Metabolite (6-AM) Assay | Predicate Device
CEDIATM Heroin
Metabolite (6-AM) Assay
(K192943) | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Intended Use | The CEDIATM Heroin
Metabolite (6-AM) Assay is
a homogeneous
enzyme immunoassay for
the in vitro qualitative
and/or semi-quantitative
determination of the
presence of heroin
metabolite (6-AM) in
human urine at a cut-off
concentration of 10 ng/mL.
The assay is intended to be
used in laboratories and
provides a rapid analytical
screening procedure to
detect 6-Acetylmorphine in
human urine. The assay is
designed for use with a
number of clinical
chemistry analyzers. 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 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 | The CEDIATM Heroin
Metabolite (6-
Acetylmorphine, or 6-AM)
Assay is a homogeneous
enzyme immunoassay for
the in vitro qualitative
and/or semi-quantitative
determination of the
presence of heroin
metabolite (6-AM) in
human urine at a cut-off
concentration of 10 ng/mL.
The assay is intended to be
used in laboratories and
provides a rapid analytical
screening procedure to
detect 6-Acetylmorphine in
human urine. The assay is
designed for use with a
number of clinical
chemistry analyzers. 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 spectrometry (LC-
MS/MS) or permitting
laboratories to establish
quality control procedures.
The assay provides only a
preliminary analytical test
result A more specific | Identical |
| Characteristics | Candidate Device
CEDIA™ Heroin
Metabolite (6-AM) Assay | Predicate Device
CEDIA™ Heroin
Metabolite (6-AM) Assay
(K192943) | Comparison |
| | method must be used to
obtain a confirmed
analytical result. Gas
chromatography/mass
spectrometry (GC/MS) or
Liquid chromatography/
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. | alternative chemical
method must be used to
obtain a confirmed
analytical result. Gas
chromatography/mass
spectrometry (GC/MS) or
Liquid chromatography/
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 | DJG | DJG | Identical |
| Device
Classification
and Name | Class II, 21 CFR 862.3650
- Opiate test
system, 91 – Toxicology | Class II, 21 CFR 862.3650 -
Opiate test
system, 91 – Toxicology | Identical |
| Operating
Principle
(Technology) | CEDIA | CEDIA | Identical |
| Analyte | 6-Acetylmorphine | 6-Acetylmorphine | Identical |
| Characteristics | Candidate Device
CEDIA™ Heroin
Metabolite (6-AM) Assay | Predicate Device
CEDIA™ Heroin
Metabolite (6-AM) Assay | Comparison |
| | | (K192943) | |
| Measured
Analyte | Heroin and 6-
Acetylmorphine | Heroin and 6-
Acetylmorphine | Identical |
| Test Matrix | Human Urine | Human Urine | Identical |
| Cut-off Levels | 10 ng/mL | 10 ng/mL | Identical |
| Methodology | Homogeneous Enzyme
Immunoassay | Homogeneous Enzyme
Immunoassay | Identical |
| Materials | Assay contains buffer salts,
stabilizer, and preservative,
BSA. Assay contains mouse
monoclonal anti-6-
Acetylmorphine derivative
antibody, Enzyme Acceptor
(Escherichia Coli), and
Enzyme Donor (Escherichia
Coli) Conjugated to 6-
Acetylmorphine
derivative | Assay contains buffer salts,
stabilizer, and preservative,
BSA. Assay contains mouse
monoclonal anti-6-
Acetylmorphine derivative
antibody, Enzyme Acceptor
(Escherichia Coli), and
Enzyme Donor (Escherichia
Coli) Conjugated to 6-
Acetylmorphine derivative | Identical |
| Reagent Form | EA and ED:
Lyophilized
(Reconstitution Required)
EARB and EDRB: Liquid
ready-to-use | EA and ED: Lyophilized
(Reconstitution Required)
EARB and EDRB: Liquid
ready-to-use | Identical |
| Characteristics | Candidate Device
CEDIA™ Heroin
Metabolite (6-AM) Assay | Predicate Device
CEDIA™ Heroin
Metabolite (6-AM) Assay
(K192943) | Comparison |
| Antibody | Mouse Monoclonal
Antibodies | Mouse Monoclonal
Antibodies | Identical |
| Storage | 2-8°C until expiration
date | 2-8°C until expiration date | Identical |
| Principal
Operator | Trained professionals | Trained professionals | Identical |
| Instrument | Horiba Yumizen C1200 | Horiba Pentra C400 | Different
clinical
chemistry
Analyzer |
6
7
8
Summary of Performance Testing VI.
A. Precision:
For Qualitative and semi-quantitative mode. ≥ 95% of samples below the cutoff read as neqative and ≥ 95% of samples above the cutoff read as positive.
B. Spike Recovery:
In qualitative mode, there is no ± 2SD overlap between the spiked 10 ng/mL, 7.5 and 12.5 ng/mL samples. All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples are detected as Negative and Positive, respectively, when compared to 10 ng/mL spiked sample.
In semi-quantitative mode, the spiked samples recover within 80–120% of the nominal values.
C. Dilution Linearity:
The assay demonstrates linearity throughout the calibration range of 0 to 20 ng/mL and R > 0.99. The mean recovery at each level is within 80-120% of expected values.
D. Method Comparison:
9
The negative agreement in qualitative mode is 100% and semi-quantitative mode is 98.4%. The positive agreement in qualitative mode is 100% and Semi-quantitative mode is 98.3%. The overall correlation agreement in Qualitative mode is 100% and Semi-quantitative mode is 98.4%.
E. Specificity:
Cross-Reactivity
The assay is specific for 6-Acetylmorphine and demonstrates cross-reactivity to heroin. Minimal cross-reactivity is observed with other structurally related and unrelated compounds.
Interference
Results demonstrate that there is no significant interference from the endogenous and exogenous substances in human urine at the tested concentrations, in samples within pH range of 3-11 and in samples with specific gravity within 1.000-1.030.
F. Stability:
Reagent On-Board Stability
Reagent On-Board stability studies for one lot stored on-board clinical analyzer supports the claim of 60 days for qualitative and semi-quantitative modes.
Reconstituted Reagent Stability
Reconstituted Reagent stability studies for one lot stored at 2-8°C supports the claim of 60 days for qualitative and semi-quantitative modes.
Open Vial Stability
Open Vial stability studies for one lot stored at 2-8°C supports the claim of 60 days for qualitative and semi-quantitative modes. This data was presented in the original 510(k) submission K192943.
Real Time Stability for Reagent
Real time stability studies for three lots of reagents stored at 2–8°C have been carried out for up to 26 months. Proposed shelf-life claim is 24 months. This data was presented in the 510(k) submission K192943.
VII. Conclusion
The information supports a determination of substantial equivalence between CEDIA™ Heroin Metabolite (6-AM) Assay and the predicate device CEDIA™ Heroin Metabolite (6-AM) Assay (K192943).