(31 days)
Not Found
No
The description details a standard enzyme immunoassay kit and its components, with no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on chemical reactions and standard laboratory procedures.
No.
This device is an in-vitro diagnostic assay intended for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers, not for therapeutic purposes.
Yes
The device is an "in-vitro device for prescription use only" that performs "qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers." It is used to generate "preliminary analytical test result" for drug of abuse testing for cannabinoids.
No
The device description explicitly states that the assay consists of antibody/substrate reagent and enzyme conjugate reagent, which are physical components. It also mentions calibrators and controls which are liquid and ready to use. This indicates a physical in-vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "This in-vitro device is for prescription use only." The term "in-vitro device" is synonymous with IVD.
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device performs a test on human urine to detect Cannabinoids.
- Purpose: The assay is intended for the "qualitative and semi-quantitative analysis of Cannabinoids in human urine." This analysis is performed in vitro (outside the body) on a biological sample.
- Components: The device description details reagents, calibrators, and controls used to perform the test on the urine sample. These are typical components of an IVD.
- Testing Method: The use of a homogeneous enzyme immunoassay on automated clinical chemistry analyzers is a common method for in vitro diagnostic testing.
- Confirmatory Methods: The mention of confirmatory methods like GC-MS or LC/MS further reinforces that this initial test is an in vitro diagnostic screening tool.
Therefore, based on the provided information, the Immunalysis Cannabinoids Urine Enzyme Immunoassay is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against 11-nor-9-carboxy-A9-THC (cTHC). This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.
Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
LDJ, DLJ, LAS
Device Description
-
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
-
All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control and HIGH Control are prepared by spiking known concentrations of 11-nor-9-carboxy-Δ'-THC (cTHC) into the negative calibrator matrix. The negative calibrator, Level 1 calibrator, Level 2 calibrator, Level 3 calibrator, Level 4 calibrator and two controls are sold as individual bottles.
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, 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
Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Precision/Cutoff Characterization Study:
- Study type: Precision study to characterize cutoff.
- Sample size: 80 determinations (20 days, 2 runs per day in duplicate).
- Key results: Verified that the cutoff of 50 ng/mL serves as a boundary between negative and positive interpretation. At the 50ng/mL cutoff, 40 negative and 40 positive results were observed in qualitative analysis, and 38 negative and 42 positive in semi-quantitative analysis.
-
Specificity and Cross-Reactivity:
- Study type: Evaluation of specificity and cross-reactivity with structurally similar compounds.
- Key results: Demonstrated cross-reactivity:
- 11-nor-9-carboxy-Δ9-THC: 100.0%
- (±) 11-Hydroxy-Δ9-THC: 50.0%
- 11-nor-Δ8-carboxy-THC: 125.0%
- Cannabinol: 66.7%
- Cannabidiol:
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
IMMUNALYSIS CORPORATION MR JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DR POMONA CA 91767
Re: K151203
Trade/Device Name: Immunalysis Cannabinoids Urine Enzyme Immunoassay. Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DLJ, LAS Dated: May 4, 2015 Received: May 5, 2015
Dear Mr. Joseph Ginete:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K151203
Device Name
Immunalysis Cannabinoids Urine Enzyme Immunoassay Immunalvsis cTHC Urine Control Set Immunalysis cTHC Urine Calibrators
Indications for Use (Describe)
The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against 11-nor-9-carboxy-A9-THC (cTHC). This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.
Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.
Type of Use (Select one or both, as applicable)
| For Transportation (49 CFR 390 Subpart B) | For-Hire Operation (49 CFR 390 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
- A. Contact Information
| A. Contact Information | ||
|---|---|---|
| 1. Manufacturer: | Immunalysis Corporation | |
| 2. Contact Name: | Joseph Ginete | |
| 3. Contact Title: | Regulatory Affairs Specialist II | |
| 4. Address: | 829 Towne Center Drive Pomona, CA 91767 | |
| 5. Phone: | (909) 482-0840 | |
| 6. Fax: | (909) 482-0850 | |
| 7. Email: | jginete@immunalysis.com | |
| 8. Summary prepared on: | June 03, 2015 | |
| B. Device Information | ||
| 1. Trade Name: | Immunalysis Cannabinoids Urine Enzyme Immunoassay | |
| Immunalysis cTHC Urine Control Set | ||
| Immunalysis cTHC Urine Calibrators | ||
| 2. Common Name: | Immunalysis Cannabinoids Urine Enzyme Immunoassay | |
| Immunalysis cTHC Urine Control Set | ||
| Immunalysis cTHC Urine Calibrators | ||
| 3. Device Classification: | II | |
| 4. Regulation Number: | CFR 862.3870 Enzyme Immunoassay, Cannabinoids | |
| CFR 862.3200 Calibrator, Drug Specific | ||
| CFR 862.3280 Clinical Toxicology Control Materials | ||
| 5. Panel: | Toxicology(91) | |
| 6. Product Code: | LDJ | |
| DLJ | ||
| LAS |
4
IMMUNALYSIS
- C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
| 1. Predicate Device: | LZI Cannabinoids (cTHC) Enzyme Immunoassay |
|---|---|
| LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) | |
| Calibrators | |
| LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) | |
| Controls | |
| 2. Predicate Company: | Lin-Zhi Internationals, Inc. |
| 3. Predicate K Number: | K110239 |
D. Device Description
-
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
-
- All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control and HIGH Control are prepared by spiking known concentrations of 11-nor-9-carboxy-Δ'-THC (cTHC) into the negative calibrator matrix. The negative calibrator, Level 1 calibrator, Level 2 calibrator, Level 3 calibrator, Level 4 calibrator and two controls are sold as individual bottles. The concentration of cTHC in their corresponding calibrators and controls are summarized as follows:
| Table 1 Immunalysis cTHC Urine Calibrators and Controls | ||||||
|---|---|---|---|---|---|---|
| Analyte | cTHC Calibrators | cTHC Controls | ||||
| Level 1 | Level 2 | Level 3 | Level 4 | LOW Control 1 | HIGH Control 1 | |
| cTHC | 20ng/mL | 50ng/mL | 100ng/mL | 2000ng/mL | 37.5ng/mL | 62.5ng/mL |
E. Intended Use
-
- The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against cTHC. This in-vitro device is for prescription use only.
5
IMMUNALYSIS
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
-
- Immunalysis cTHC Urine Control: The Immunalysis cTHC Urine Controls are used as control materials in Immunalysis Cannabinoids Urine Enzyme Immunoassay.
-
- Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.
| Item | Cannabinoids Assay K110239 | Immunalysis Cannabinoids Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi- | |
| quantitative determination of the | ||
| presence of Cannabinoids in human | ||
| urine at a cutoff of 25ng/mL, | ||
| 50ng/mL and 100ng/mL | For the qualitative and semi-quantitative | |
| determination of the presence of | ||
| Cannabinoids in human urine at a cutoff of | ||
| 50ng/mL | ||
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Cannabinoids | Cannabinoids |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 25ng/mL, 50ng/mL and 100ng/mL of | |
| Cannabinoids | 50ng/mL of Cannabinoids | |
| Test System | Homogeneous Enzyme Immunoassay | Homogenous Enzyme Immunoassay |
| Materials | Liquid Ready-to-Use Two Reagent | |
| Assay (R1 and R2) | Antibody/Substrate Reagents and Enzyme | |
| Labeled Conjugate | ||
| Mass Spectroscopy | ||
| Confirmation | Required for preliminary positive | |
| analytical results | Required for preliminary positive | |
| analytical results | ||
| Antibody | Mouse Monoclonal antibodies to | |
| Cannabinoids | Monoclonal and polyclonal antibodies to | |
| Cannabinoids | ||
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Three sets of Five (5) Levels | Five (5) Levels (including negative) |
| Control Levels | Three sets of Two (2) Levels | Two (2) Levels |
- F. Comparison of the new device with the predicate device
6
- G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Cannabinoids Urine Enzyme Immunoassay to the predicate
-
- Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. The instruments used for this was Beckman Coulter AU 400e.
-
| 50ng/mL cutoff test data results. | |||
|---|---|---|---|
| Table 2 - Qualitative Analysis (for 50ng/mL cutoff) | |||
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 12.5 | -75% | 80 | 80 Negative |
| 25 | -50% | 80 | 80 Negative |
| 37.5 | -25% | 80 | 80 Negative |
| 50 | Cutoff | 80 | 40 Negative/40 Positive |
| 62.5 | +25% | 80 | 80 Positive |
| 75 | +50% | 80 | 80 Positive |
| 87.5 | +75% | 80 | 80 Positive |
| 100 | +100% | 80 | 80 Positive |
- a. The following is a summary table of the Qualitative Analysis for the
b. The following is a summary table of the Semi-Quantitative Analysis for the 50ng/mL cutoff test data results.
| Table 3 - Semi-Quantitative Analysis (for 50ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 12.5 | -75% | 80 | 80 Negative |
| 25 | -50% | 80 | 80 Negative |
| 37.5 | -25% | 80 | 80 Negative |
| 50 | Cutoff | 80 | 38 Negative/42 Positive |
| 62.5 | +25% | 80 | 80 Positive |
| 75 | +50% | 80 | 80 Positive |
| 87.5 | +75% | 80 | 80 Positive |
| 100 | +100% | 80 | 80 Positive |
-
- Specificity and Cross-Reactivity - Structurally similar compounds were spiked into drug free urine at levels that will vield a result that is equivalent to the cutoffs. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. The instrument used for this test was a Beckman Coulter AU 400e.
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| below: | |||
|---|---|---|---|
| Table 4 - Structurally Related Compounds (for 50 ng/mL cutoff) - Qualitative | |||
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| 11-nor-9-carboxy- Δ9-THC | 50 | Positive | 100.0 |
| (±) 11-Hydroxy- Δ9-THC | 100 | Positive | 50.0 |
| 11-nor- Δ8-carboxy-THC | 40 | Positive | 125.0 |
| Cannabinol | 75 | Positive | 66.7 |
| Cannabidiol | 1,000,000 | Negative | 75 ng/mL |
| Qualitative/ Positive | 0 | 0 | 10 |
| Qualitative/ Negative | 36 | 4 | 0 |
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- c. The following is a comparison table of semi-quantitative assay performance for the 50ng/mL cutoff:
Table 14 - Method Comparison (for 50ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | ||
|---|---|---|
| (+) | (-) | |
| Test | ||
| Device | 40 | 0 |
| (+) | 0 | 40 |
d. The following is a summary table of semi-quantitative assay performance for the 50ng/mL cutoff:
| Table 15 - Assay Performance verified by LC/MS – 50ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Cannabinoids Concentration | Agreement (%) | |||
| 75 ng/mL | |||||
| Semi-Quantitative/ Positive | 0 | 0 | 10 | 30 | 100 |
| Semi-Quantitative / Negative | 36 | 4 | 0 | 0 | 100 |
-
- Calibrator and Control Analytical Performance Immunalysis cTHC Urine Calibrators and Controls
- a. cTHC Calibrator and Control Traceability all components of the calibrator and controls have been traced to a commercially available standard solution
- b.cTHC Calibrators and Controls Stability A closed vial stability study was performed at 25°C to establish the initial vial expiration dating. The stability study supported an initial expiration date of 12 months. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control and High Control) for cTHC were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- c.cTHC Calibrators and Controls Stability An open vial stability study was performed at 5℃ to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 60 days. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control and High Control) for cTHC were within specifications for Day 0, 7, 14, 21, 30, 45 and 60. This stability study was performed to establish initial expiration dating.
- d.cTHC Calibrator and Control Value Assignment Calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrator and controls is adjusted and re-tested. Values are assigned to the calibrators and controls once the mass spectrometry results are within the acceptable ranges.
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H. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Cannabinoids Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.