(161 days)
The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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 Opiates Urine Calibrators 300
The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Immunalysis Multi-Drug Controls
The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Immunalysis Opiates Urine Calibrators 2000
The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
All of the Immunalysis Opiates Urine Calibrators 300 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.
All of the Immunalysis Multi-Drug 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets.
All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.
The provided document describes the Immunalysis Opiates Urine Enzyme Immunoassay and related calibrators and controls. The focus of the acceptance criteria and study is on the analytical performance of the immunoassay for detecting opiates in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity values to be achieved). Instead, it presents the results of various analytical performance studies and implies that these results demonstrate substantial equivalence to predicate devices. The "reported device performance" is the outcome of these studies.
I will attempt to extract what could be interpreted as performance metrics and their results for the Immunoassay, focusing on the Qualitative Analysis and Method Comparison, as these are closest to typical acceptance criteria.
Note: The document provides performance for two cut-off levels: 300 ng/mL and 2000 ng/mL. The following table consolidates performance for both where applicable.
| Acceptance Criterion (Implicit) | Reported Device Performance (300 ng/mL cutoff) | Reported Device Performance (2000 ng/mL cutoff) |
|---|---|---|
| Precision/Cutoff Characterization (Qualitative) | Concentration (ng/mL) vs. Result (N=80 for each): | Concentration (ng/mL) vs. Result (N=80 for each): |
| Ability to correctly classify samples at -100% of cutoff | 0 ng/mL: 80 Negative (100%) | 0 ng/mL: 80 Negative (100%) |
| Ability to correctly classify samples at -75% of cutoff | 75 ng/mL: 80 Negative (100%) | 500 ng/mL: 80 Negative (100%) |
| Ability to correctly classify samples at -50% of cutoff | 150 ng/mL: 80 Negative (100%) | 1000 ng/mL: 80 Negative (100%) |
| Ability to correctly classify samples at -25% of cutoff | 225 ng/mL: 80 Negative (100%) | 1500 ng/mL: 80 Negative (100%) |
| Performance at Cutoff | 300 ng/mL: 37 Negative / 43 Positive (46.25% Negative, 53.75% Positive) - Indicates cutoff boundary behavior | 2000 ng/mL: 42 Negative / 38 Positive (52.5% Negative, 47.5% Positive) - Indicates cutoff boundary behavior |
| Ability to correctly classify samples at +25% of cutoff | 375 ng/mL: 80 Positive (100%) | 2500 ng/mL: 80 Positive (100%) |
| Ability to correctly classify samples at +50% of cutoff | 450 ng/mL: 80 Positive (100%) | 3000 ng/mL: 80 Positive (100%) |
| Ability to correctly classify samples at +75% of cutoff | 525 ng/mL: 80 Positive (100%) | 3500 ng/mL: 80 Positive (100%) |
| Ability to correctly classify samples at +100% of cutoff | 600 ng/mL: 80 Positive (100%) | 4000 ng/mL: 80 Positive (100%) |
| Method Comparison (Qualitative) vs. LC/MS Confirmation | ||
| Agreement for Positive results | 40 True Positive (Test Device Positive, LC/MS Positive) | 40 True Positive (Test Device Positive, LC/MS Positive) |
| Agreement for Negative results | 39 True Negative (Test Device Negative, LC/MS Negative) | 40 True Negative (Test Device Negative, LC/MS Negative) |
| False Positives (Test Device Positive, LC/MS Negative) | 1 False Positive | 0 False Positives |
| False Negatives (Test Device Negative, LC/MS Positive) | 0 False Negatives | 0 False Negatives |
| Overall Agreement at < 150ng/mL | 100% Negative Agreement (36 samples) | 100% Negative Agreement (36 samples) for <1000ng/mL |
| Overall Agreement at 150-299ng/mL | 97.4% (3 of 3 Negative agreement, 1 of 1 Positive agreement) - 1 discordant result | N/A (4 of 4 Negative agreement) for 1000-1999ng/mL |
| Overall Agreement at 300-450ng/mL | 100% Positive Agreement (5 samples) | 100% Positive Agreement (5 samples) for 2000-3000ng/mL |
| Overall Agreement at > 450ng/mL | 100% Positive Agreement (35 samples) | 100% Positive Agreement (35 samples) for >3000ng/mL |
| Specificity to Structurally Similar Compounds (Cross-Reactivity) | Various % cross-reactivity for other opiates (e.g., Codeine 150.0%, Hydrocodone 75.0%, Naloxone 0.5%). Acceptance is implied by presenting these values for user information. | Various % cross-reactivity for other opiates (e.g., Dihydrocodeine 333.3%, Hydrocodone 50.0%, Naloxone 0.4%). Acceptance is implied by presenting these values for user information. |
| Interference (Structurally Non-Similar Compounds, Endogenous, pH, Specific Gravity) | Generally "No" interference for most compounds tested at ±25% of cutoff, except for Boric Acid and Riboflavin causing false negatives. Implied acceptance is demonstration of minimal interference, and clearly identifying those observed | Generally "No" interference for most compounds tested at ±25% of cutoff, except for Boric Acid and Riboflavin causing false negatives. Implied acceptance is demonstration of minimal interference, and clearly identifying those observed |
| Linearity/Recovery | Recovery % ranging from 91.6% to 108.5% over expected concentrations (100-1100 ng/mL). Implied acceptance is a reasonable recovery range. | Recovery % ranging from 93.0% to 107.2% over expected concentrations (600-6600 ng/mL). Implied acceptance is a reasonable recovery range. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision/Cutoff Characterization Study: 80 determinations for each concentration level (e.g., 0 ng/mL, 75 ng/mL, 150 ng/mL, etc.) for both 300 ng/mL and 2000 ng/mL cutoffs. This was performed over 20 days, 2 runs per day in duplicate (N=80). The samples for this study would be spiked laboratory samples (morphine in drug-free urine). The provenance is laboratory-controlled.
- Specificity and Cross-Reactivity: Compounds were spiked into drug-free urine. The number of determinations per compound is not explicitly stated but implies tests at a single "Concentration Tested."
- Interference: Potential interferents were spiked into drug-free urine containing morphine at ±25% of the cutoffs. The number of determinations per compound and condition is not explicitly stated.
- Linearity/Recovery: A drug-free urine pool was spiked with a high concentration of the target analyte, then serially diluted. The number of samples for each expected concentration is not directly stated, but the "Mean Concentration" implies multiple measurements.
- Method Comparison: "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories" were used.
- For the 300 ng/mL cutoff, the tables indicate a total of 80 clinical samples (40 positive by LC/MS, 40 negative by LC/MS, with one discordant result).
- For the 2000 ng/mL cutoff, the tables indicate a total of 80 clinical samples (40 positive by LC/MS, 40 negative by LC/MS).
- Data Provenance: Retrospective, anonymous discarded clinical urine samples. The country of origin is not specified but implicitly in the USA as per FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an in-vitro diagnostic assay for chemical analysis. The "ground truth" for the test set (clinical urine samples) was established using Liquid Chromatography/Mass Spectrometry (LC/MS) confirmation. This is an analytical method, not human expert consensus, for determining the presence and concentration of chemical substances. Therefore, human experts were not directly used to establish the ground truth in the way they might be for interpreting medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth was established by an objective analytical method (LC/MS confirmation), not by expert opinion. Therefore, no human adjudication method was required.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an immunoassay for chemical testing, not an imaging device or an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "Homogeneous Enzyme Immunoassay," which operates as a standalone analytical test system on automated clinical chemistry analyzers. Its performance, as reported in the studies (Precision, Specificity, Interference, Linearity, and Method Comparison with LC/MS), represents its standalone performance without explicit human interpretation determining the positive/negative result (though lab personnel operate the instrument and interpret the final reported value). The "semi-quantitative mode" is explicitly stated for aiding decisions on confirmation methods or quality control, not as a human-in-the-loop diagnostic where a human modifies the device's direct output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical urine samples used in the method comparison study was established by Liquid Chromatography/Mass Spectrometry (LC/MS) confirmation, which is considered the preferred confirmatory method for drug of abuse testing.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI. This is an immunoassay, which is a chemical analytical test, not a learning algorithm. The studies performed are characterization and validation studies for the assay's analytical performance.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device reliant on a training set. The "ground truth" in the validation studies was established via spiked samples (known concentrations) for various performance characteristics and LC/MS for clinical sample comparison.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DR POMONA CA 91767
May 20, 2015
Re: K143502
Trade/Device Name: Immunalysis Opiates Urine Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Multi-Drug Controls Immunalysis Opiates Urine Calibrators 2000 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II
Product Code: DJG, DLJ, DIF Dated: March 26, 2015 Received: March 27, 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
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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/ResourcesforYou/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,
Katherine Serrano -S
For: 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
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Indications for Use
510(k) Number (if known) K143502
Device Name
Immunalysis Opiates Urine Enzyme Immunalysis Opiates Urine Calibrators 300, Immunalysis Multi-Drug Controls, and Immunalysis Opiates Urine Calibrators 2000
Indications for Use (Describe)
Immunalysis Opiates Urine Enzyme Immunoassay
The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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 Opiates Urine Calibrators 300
The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Immunalysis Multi-Drug Controls
The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Immunalysis Opiates Urine Calibrators 2000
The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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B.
C.
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
| 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: | May 18, 2015 |
| Device Information | ||
| 1. | Trade Name: | Immunalysis Opiates Urine Enzyme Immunoassay |
| Immunalysis Opiates Urine Calibrators 300 | ||
| Immunalysis Multi-Drug Controls | ||
| Immunalysis Opiates Urine Calibrators 2000 | ||
| 2. | Common Name: | Immunalysis Opiates Urine Enzyme Immunoassay |
| Immunalysis Opiates Urine Calibrators 300 | ||
| Immunalysis Multi-Drug Controls | ||
| Immunalysis Opiates Urine Calibrators 2000 | ||
| Regulatory Information | ||
| 1. | Device Classification: | II |
| 2. | Regulation Number: | CFR 862.3650 Opiate Test System |
| CFR 862.3200 Clinical Toxicology Calibrator | ||
| CFR 862.3280 Clinical Toxicology ControlMaterials | ||
| 3. | Panel: | Toxicology(91) |
| 4. | Product Code: | DJG |
| DLJ | ||
| DJE |
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IMMUNALYSIS
- D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
| 1. Predicate Device: | DRI® DAU Opiate Assay |
|---|---|
| LZI Multiple Analyte Urine Drugs of Abuse | |
| Calibrators and Controls | |
| 2. Predicate Company: | Microgenics |
| Lin-Zhi International, Inc. | |
| 3. Predicate K Number: | K011150 |
| K051088 |
E. Device Description
-
- The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
-
- All of the Immunalysis Opiates Urine Calibrators 300 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. The concentration of morphine in their corresponding calibrators are summarized as follows:
| Table 1 Immunalysis Opiates Urine Calibrators 300 | ||||
|---|---|---|---|---|
| Analyte | Opiates Calibrators | |||
| Level 1 | Level 2 | Level 3 | Level 4 | |
| Morphine | 100ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL |
-
- All of the Immunalysis Multi-Drug 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets. The concentration of drug analyte in their corresponding controls are summarized as follows:
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| Table 2 Immunalysis Multi-Drug Controls 1 | ||
|---|---|---|
| Analyte | Multi-Drug Controls | |
| LOW Control 1 | HIGH Control 1 | |
| Benzoylecgonine | 112.5ng/mL | 187.5ng/mL |
| Methadone | 225ng/mL | 375ng/mL |
| Methamphetamine | 375ng/mL | 625ng/mL |
| Morphine | 225ng/mL | 375ng/mL |
| PCP | 19ng/mL | 31ng/mL |
| Secobarbital | 150ng/mL | 250ng/mL |
| Oxazepam | 150ng/mL | 250ng/mL |
| Table 3 Immunalysis Multi-Drug Controls 2 | ||
|---|---|---|
| Multi-Drug Controls | ||
| Analyte | LOW Control 2 | HIGH Control 2 |
| Benzoylecgonine | 225ng/mL | 375ng/mL |
| Methamphetamine | 750ng/mL | 1250ng/mL |
| Morphine | 1500ng/mL | 2500ng/mL |
-
- All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. The concentration of morphine in the corresponding calibrators are summarized as follows:
| Table 4 Immunalysis Opiates Urine Calibrators 2000 | ||||
|---|---|---|---|---|
| Opiates Calibrators | ||||
| Analyte | Level 1 | Level 2 | Level 3 | Level 4 |
| Morphine | 1000ng/mL | 2000ng/mL | 4000ng/mL | 6000ng/mL |
- F. Intended Use
- The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme 1. immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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.
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IMMUNALYSIS
-
- The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
- The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
| Item | Opiates Assay K011150 | Immunalysis Opiates Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300ng/mL and 2000ng/mL | For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300ng/mL and 2000ng/mL |
| Type of Product | Analytical Reagents | Analytical Reagents |
| MeasuredAnalytes | Opiates | Opiates |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 300ng/mL and 2000ng/mL ofMorphine | 300ng/mL and 2000ng/mL ofMorphine |
| Test System | Homogeneous EnzymeImmunoassay | Homogeneous EnzymeImmunoassay (EIA) |
| Materials | Antibody/Substrate Reagents andEnzyme Labeled Conjugate | Antibody/Substrate Reagents andEnzyme Labeled Conjugate |
| MassSpectroscopyConfirmation | Required for preliminary positiveanalytical results | Required for preliminary positiveanalytical results |
| Antibody | Monoclonal antibody to Opiates | Monoclonal antibody to Opiates |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
- G. Comparison of the new device with the predicate device
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IMMUNALYSIS
| Item | LZI Multiple Analyte K051088 | Immunalysis Opiates UrineCalibrators 300 |
|---|---|---|
| Analyte | benzoylecgonine, d-methamphetamine, methadone,morphine, oxazepam, secobarbital,phencyclidine, propoxyphene | Morphine |
| Matrix | Urine | Same |
| Calibrator Levels | 5 Levels – See Table 5 Below | 5 Levels (Negative and Level 1, 2, 3 and4) - See Device Description Table 1 |
| Storage | 2 – 8°C until expiration date | Same |
| Item | LZI Multiple Analyte K051088 | Immunalysis Multi-Drug Controls |
|---|---|---|
| Analyte | benzoylecgonine, d-methamphetamine, methadone,morphine, oxazepam, secobarbital,phencyclidine, propoxyphene | benzoylecgonine, methadome,methamphetamine, morphine, PCP,secobarbital, oxazepam |
| Matrix | Urine | Urine |
| Control Levels | 2 Levels – See Table 5 Below | 4 Levels (LOW Control 1, HIGHControl 1, LOW Control 2 and HIGHControl 2) – See Device DescriptionTable 2 and Table 3 |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
| Item | LZI Multiple Analyte K051088 | Immunalysis Opiates UrineCalibrators 2000 |
|---|---|---|
| Analyte | benzoylecgonine, d-methamphetamine, methadone,morphine, oxazepam, secobarbital,phencyclidine, propoxyphene | Morphine |
| Matrix | Urine | Same |
| Calibrator Levels | 5 Levels – See Table 5 Below | 5 Levels (Negative and Level 1, 2, 3 and4) - See Device Description Table 4 |
| Storage | 2 - 8°C until expiration date | Same |
| Table 5 LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls | ||||||
|---|---|---|---|---|---|---|
| Analyte | Multiple Analyte Calibrators | Multiple Analyte Controls | ||||
| Low | Cutoff | Intermediate | High | Level 1 | Level 2 | |
| d-Methamphetamine | 250ng/mL | 500ng/mL | 750ng/mL | 1000ng/mL | 375ng/mL | 625ng/mL |
| Morphine | 1000ng/mL | 2000ng/mL | 4000ng/mL | 6000ng/mL | 1500ng/mL | 2500ng/mL |
| Phencyclidine | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL | 18ng/mL | 35ng/mL |
| Benzoylecgonine | 75ng/mL | 150ng/mL | 300ng/mL | 1000ng/mL | 110ng/mL | 190ng/mL |
| Oxazepam | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL | 100ng/mL | 300ng/mL |
| Secobarbital | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL | 100ng/mL | 300ng/mL |
| Propoxyphene | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL | 225ng/mL | 375ng/mL |
| Methadone | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL | 225ng/mL | 375ng/mL |
{9}------------------------------------------------
- H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Opiates 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. In addition, it also verified the product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was a Beckman Coulter AU 400e.
-
| a. The following is a summary table of the Qualitative Analysis for the | |
|---|---|
| 300ng/mL cutoff test data results. |
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 75 | -75% | 80 | 80 Negative |
| 150 | -50% | 80 | 80 Negative |
| 225 | -25% | 80 | 80 Negative |
| 300 | Cutoff | 80 | 37 Negative/43 Positive |
| 375 | +25% | 80 | 80 Positive |
| 450 | +50% | 80 | 80 Positive |
| 525 | +75% | 80 | 80 Positive |
| 600 | +100% | 80 | 80 Positive |
b. The following is a summary table of the Qualitative Analysis for the 2000ng/mL cutoff test data results.
| Table 7 - Qualitative Analysis (for 2000ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 500 | -75% | 80 | 80 Negative |
| 1000 | -50% | 80 | 80 Negative |
| 1500 | -25% | 80 | 80 Negative |
| 2000 | Cutoff | 80 | 42 Negative/38 Positive |
| 2500 | +25% | 80 | 80 Positive |
| 3000 | +50% | 80 | 80 Positive |
| 3500 | +75% | 80 | 80 Positive |
| 4000 | +100% | 80 | 80 Positive |
c. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results.
| Table 8 - Semi-Quantitative Analysis (for 300ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 75 | -75% | 80 | 80 Negative |
| 150 | -50% | 80 | 80 Negative |
| 225 | -25% | 80 | 80 Negative |
| 300 | Cutoff | 80 | 20 Negative/60 Positive |
| 375 | +25% | 80 | 80 Positive |
{10}------------------------------------------------
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| Table 8 - Semi-Quantitative Analysis (for 300ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 450 | +50% | 80 | 80 Positive |
| 525 | +75% | 80 | 80 Positive |
| 600 | +100% | 80 | 80 Positive |
d. The following is a summary table of the Semi-Quantitative Analysis for the 2000ng/mL cutoff test data results.
| Table 9 - Semi-Quantitative Analysis (for 2000ng/mL cutoff) | ||||
|---|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result | |
| 0 | -100% | 80 | 80 Negative | |
| 500 | -75% | 80 | 80 Negative | |
| 1000 | -50% | 80 | 80 Negative | |
| 1 200 | -25% | 80 | 80 Negative | |
| 2000 | Cutoff | 80 | 41 Negative/39 Positive | |
| 2500 | +25% | 80 | 80 Positive | |
| 3000 | +50% | 80 | 80 Positive | |
| 3500 | +75% | 80 | 80 Positive | |
| 4000 | +100% | 80 | 80 Positive |
-
- Specificity and Cross-Reactivity Structurally similar compounds were spiked into drug free urine at levels that will yield 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.
- a. The qualitative result summary table for the 300ng/mL cutoffs is outlined below:
| Table 10 - Structurally Related Compounds (for 300ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| 6-Acetylmorphine | 150 | POS | 200.0 |
| Codeine | 200 | POS | 150.0 |
| Dihydrocodeine | 150 | POS | 200.0 |
| Ethylmorphine | 300 | POS | 100.0 |
| Heroin | 300 | POS | 100.0 |
| Hydrocodone | 400 | POS | 75.0 |
| Levorphanol | 8,000 | POS | 3.8 |
| Morphine-3-Glucuronide | 200 | POS | 150.0 |
| Morphine-6-Glucuronide | 100 | POS | 300.0 |
| Hydromorphone | 700 | POS | 42.9 |
| Nalorphine | 2,000 | POS | 15.0 |
| Naloxone | 60,000 | POS | 0.5 |
| Norcodeine | 25,000 | POS | 1.2 |
| Normorphine | 25,000 | POS | 1.2 |
| Oxycodone | 10,000 | POS | 3.0 |
| Oxymorphone | 20,000 | POS | 1.5 |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color and there are no other objects in the image.
b. The qualitative result summary table for the 2000ng/mL cutoff is outlined below:
| Table 11 - Structurally Related Compounds (for 2000ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| 6-Acetylmorphine | 2,000 | POS | 100.0 |
| Codeine | 2,000 | POS | 100.0 |
| Dihydrocodeine | 600 | POS | 333.3 |
| Ethylmorphine | 2,000 | POS | 100.0 |
| Heroin | 4,000 | POS | 50.0 |
| Hydrocodone | 4,000 | POS | 50.0 |
| Levorphanol | 100,000 | POS | 2.0 |
| Morphine-3-Glucuronide | 2,000 | POS | 100.0 |
| Morphine-6-Glucuronide | 600 | POS | 333.3 |
| Hydromorphone | 8,000 | POS | 25.0 |
| Nalorphine | 28,000 | POS | 7.1 |
| Naloxone | 500,000 | POS | 0.4 |
| Norcodeine | 300,000 | POS | 0.7 |
| Normorphine | 300,000 | POS | 0.7 |
| Oxycodone | 100,000 | POS | 2.0 |
| Oxymorphone | 200,000 | NEG | 1.0 |
c. The semi-quantitative result summary table for the 300ng/mL cutoff is outlined below:
| Table 12 - Structurally Related Compounds (for 300ng/mL cutoff) – Semi-Quantitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| 6-Acetylmorphine | 150 | POS | 200.0 |
| Codeine | 200 | NEG | 150.0 |
| Dihydrocodeine | 150 | POS | 200.0 |
| Ethylmorphine | 300 | POS | 100.0 |
| Heroin | 300 | POS | 100.0 |
| Hydrocodone | 400 | POS | 75.0 |
| Levorphanol | 8,000 | POS | 3.8 |
| Morphine-3-Glucuronide | 200 | POS | 150.0 |
| Morphine-6-Glucuronide | 100 | POS | 300.0 |
| Hydromorphone | 700 | POS | 42.9 |
| Nalorphine | 2,000 | POS | 15.0 |
| Naloxone | 60,000 | POS | 0.5 |
| Norcodeine | 25,000 | POS | 1.2 |
| Normorphone | 25,000 | POS | 1.2 |
| Oxycodone | 10,000 | POS | 3.0 |
| Oxymorphone | 20,000 | POS | 1.5 |
{12}------------------------------------------------
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| Table 13 - Structurally Related Compounds (for 2000ng/mL cutoff) – Semi-Quantitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| 6-Acetylmorphine | 2,000 | POS | 100.0 |
| Codeine | 2,000 | POS | 100.0 |
| Dihydrocodeine | 600 | POS | 333.3 |
| Ethylmorphine | 2,000 | POS | 100.0 |
| Heroin | 4,000 | POS | 50.0 |
| Hydrocodone | 4,000 | POS | 50.0 |
| Levorphanol | 100,000 | POS | 2.0 |
| Morphine-3-Glucuronide | 2,000 | POS | 100.0 |
| Morphine-6-Glucuronide | 600 | POS | 333.3 |
| Hydromorphone | 8,000 | POS | 25.0 |
| Nalorphine | 28,000 | POS | 7.1 |
| Naloxone | 500,000 | POS | 0.4 |
| Norcodeine | 300,000 | POS | 0.7 |
| Normorphine | 300,000 | POS | 0.7 |
| Oxycodone | 100,000 | POS | 2.0 |
| Oxymorphone | 200,000 | NEG | 1.0 |
- d. The semi-quantitative result summary table for the 2000ng/mL cutoff is outlined below:
-
- Interference Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferents into drug free urine containing morphine at ±25% of the cutoffs. Boric Acid and Riboflavin caused a false negative response at the concentrations tested. All other potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The following is a summary table of the structurally non-similar compounds for the 300ng/mL cutoff:
| Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | ||||||
|---|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | |||
| Result | Interference? | Result | Interference? | |||
| 4-Bromo-2,5,Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No | |
| Acetaminophen | 500,000 | Negative | No | Positive | No | |
| Acetylsalicylic Acid | 500,000 | Negative | No | Positive | No | |
| Alprazolam | 100,000 | Negative | No | Positive | No | |
| Amphetamine | 500,000 | Negative | No | Positive | No | |
| Amitriptyline | 100,000 | Negative | No | Positive | No | |
| Amobarbital | 100,000 | Negative | No | Positive | No | |
| Benzoylecgonine | 500,000 | Negative | No | Positive | No | |
| Benzylpiperazine | 100,000 | Negative | No | Positive | No | |
| Bromazepam | 100,000 | Negative | No | Positive | No | |
| Buprenorphine | 100,000 | Negative | No | Positive | No | |
| Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | ||||||
| Concentration | -25% Cutoff | +25% Cutoff | ||||
| Compound | Tested | (225ng/mL) | (375ng/mL) | |||
| (ng/mL) | Result | Interference? | Result | Interference? | ||
| Buprion | 100,000 | Negative | No | Positive | No | |
| Butabarbital | 100,000 | Negative | No | Positive | No | |
| Caffeine | 500,000 | Negative | No | Positive | No | |
| Carbamazepine | 100,000 | Negative | No | Positive | No | |
| Cocaine | 100,000 | Negative | No | Positive | No | |
| Clomipramine | 100,000 | Negative | No | Positive | No | |
| Clonazepam | 100,000 | Negative | No | Positive | No | |
| Chloropromazine | 100,000 | Negative | No | Positive | No | |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No | |
| N-Desmethyltapentadol | 100,000 | Negative | No | Positive | No | |
| Desipramine | 100,000 | Negative | No | Positive | No | |
| Dextromethorphan | 100,000 | Negative | No | Positive | No | |
| Diazepam | 100,000 | Negative | No | Positive | No | |
| Diphenhydramine | 500,000 | Negative | No | Positive | No | |
| Doxepin | 100,000 | Negative | No | Positive | No | |
| Ephedrine | 100,000 | Negative | No | Positive | No | |
| EDDP | 100,000 | Negative | No | Positive | No | |
| Ethyl-glucuronide | 100,000 | Negative | No | Positive | No | |
| Fenfluramine | 100,000 | Negative | No | Positive | No | |
| Fluoxetine | 100,000 | Negative | No | Positive | No | |
| Flurazepam | 100,000 | Negative | No | Positive | No | |
| Hexobarbital | 100,000 | Negative | No | Positive | No | |
| Ibuprofen | 100,000 | Negative | No | Positive | No | |
| Imipramine | 100,000 | Negative | No | Positive | No | |
| Ketamine | 100,000 | Negative | No | Positive | No | |
| Lidocaine | 100,000 | Negative | No | Positive | No | |
| LSD | 100,000 | Negative | No | Positive | No | |
| Lorazepam | 100,000 | Negative | No | Positive | No | |
| Maprotiline | 100,000 | Negative | No | Positive | No | |
| MDEA | 100,000 | Negative | No | Positive | No | |
| MDA | 100,000 | Negative | No | Positive | No | |
| MDMA | 100,000 | Negative | No | Positive | No | |
| Meperidine | 50.000 | Negative | No | Positive | No | |
| Methadone | 500,000 | Negative | No | Positive | No | |
| Methaqualone | 100,000 | Negative | No | Positive | No | |
| Methamphetamine | 500,000 | Negative | No | Positive | No | |
| Meprobamate | 100,000 | Negative | No | Positive | No | |
| Naltrexone | 100,000 | Negative | No | Positive | No | |
| Nitrazepam | 100,000 | Negative | No | Positive | No | |
| Norbuprenorphine | 100,000 | Negative | No | Positive | No | |
| Nordiazepam | 100,000 | Negative | No | Positive | No | |
| Nortryptyline | 100,000 | Negative | No | Positive | No | |
| Norpropoxyphene | 100,000 | Negative | No | Positive | No | |
| Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | ||||||
| Concentration | -25% Cutoff | +25% Cutoff | ||||
| Compound | Tested | (225ng/mL) | (375ng/mL) | |||
| (ng/mL) | Result | Interference? | Result | Interference? | ||
| Oxazepam | 100,000 | Negative | No | Positive | No | |
| Pentobarbital | 100,000 | Negative | No | Positive | No | |
| Phenobarbital | 100,000 | Negative | No | Positive | No | |
| Pentazocine | 100,000 | Negative | No | Positive | No | |
| Phencyclidine | 100,000 | Negative | No | Positive | No | |
| Phentermine | 100,000 | Negative | No | Positive | No | |
| Phenylpropanolamine | 500,000 | Negative | No | Positive | No | |
| PMA | 100,000 | Negative | No | Positive | No | |
| (-)Pseudoephedrine | 100,000 | Negative | No | Positive | No | |
| (+)Pseudoephedrine | 100,000 | Negative | No | Positive | No | |
| Phenytoin | 100,000 | Negative | No | Positive | No | |
| Protryptyline | 100,000 | Negative | No | Positive | No | |
| Ranitidine | 100,000 | Negative | No | Positive | No | |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No | |
| Secobarbital | 100,000 | Negative | No | Positive | No | |
| Sufentanil | 100,000 | Negative | No | Positive | No | |
| Temazepam | 100,000 | Negative | No | Positive | No | |
| 11-nor-9 carboxy THC | 100,000 | Negative | No | Positive | No | |
| Tramadol | 100,000 | Negative | No | Positive | No | |
| Trimipramine | 100,000 | Negative | No | Positive | No | |
| Venlafaxine | 100,000 | Negative | No | Positive | No |
{13}------------------------------------------------
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{14}------------------------------------------------
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b. The following is a summary table of the structurally non-similar compounds for the 2000ng/mL cutoff:
| Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff) | ||||||
|---|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(1500ng/mL) | +25% Cutoff(2500ng/mL) | |||
| Result | Interference? | Result | Interference? | |||
| 4-Bromo-2,5,Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No | |
| Acetaminophen | 500,000 | Negative | No | Positive | No | |
| Acetylsalicylic Acid | 500,000 | Negative | No | Positive | No | |
| Alprazolam | 100,000 | Negative | No | Positive | No | |
| Amphetamine | 500,000 | Negative | No | Positive | No | |
| Amitriptyline | 100,000 | Negative | No | Positive | No | |
| Amobarbital | 100,000 | Negative | No | Positive | No | |
| Benzoylecgonine | 500,000 | Negative | No | Positive | No | |
| Benzylpiperazine | 100,000 | Negative | No | Positive | No | |
| Bromazepam | 100,000 | Negative | No | Positive | No | |
| Buprenorphine | 100,000 | Negative | No | Positive | No | |
| Buprion | 100,000 | Negative | No | Positive | No | |
| Butabarbital | 100,000 | Negative | No | Positive | No | |
| Caffeine | 500,000 | Negative | No | Positive | No | |
| Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff) | ||||||
| Concentration | -25% Cutoff | +25% Cutoff | ||||
| Compound | Tested | (1500ng/mL) | (2500ng/mL) | |||
| (ng/mL) | Result | Interference? | Result | Interference? | ||
| Carbamazepine | 100,000 | Negative | No | Positive | No | |
| Cocaine | 100,000 | Negative | No | Positive | No | |
| Clomipramine | 100,000 | Negative | No | Positive | No | |
| Clonazepam | 100,000 | Negative | No | Positive | No | |
| Chloropromazine | 100,000 | Negative | No | Positive | No | |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No | |
| N-Desmethyltapentadol | 100,000 | Negative | No | Positive | No | |
| Desipramine | 100,000 | Negative | No | Positive | No | |
| Dextromethorphan | 100,000 | Negative | No | Positive | No | |
| Diazepam | 100,000 | Negative | No | Positive | No | |
| Diphenhydramine | 500,000 | Negative | No | Positive | No | |
| Doxepin | 100,000 | Negative | No | Positive | No | |
| Ephedrine | 100,000 | Negative | No | Positive | No | |
| EDDP | 100,000 | Negative | No | Positive | No | |
| Ethyl-glucuronide | 100,000 | Negative | No | Positive | No | |
| Fenfluramine | 100,000 | Negative | No | Positive | No | |
| Fluoxetine | 100,000 | Negative | No | Positive | No | |
| Flurazepam | 100,000 | Negative | No | Positive | No | |
| Hexobarbital | 100,000 | Negative | No | Positive | No | |
| Ibuprofen | 100,000 | Negative | No | Positive | No | |
| Imipramine | 100,000 | Negative | No | Positive | No | |
| Ketamine | 100,000 | Negative | No | Positive | No | |
| Lidocaine | 100,000 | Negative | No | Positive | No | |
| LSD | 100,000 | Negative | No | Positive | No | |
| Lorazepam | 100,000 | Negative | No | Positive | No | |
| Maprotiline | 100,000 | Negative | No | Positive | No | |
| MDEA | 100,000 | Negative | No | Positive | No | |
| MDA | 100,000 | Negative | No | Positive | No | |
| MDMA | 100,000 | Negative | No | Positive | No | |
| Meperidine | 100,000 | Negative | No | Positive | No | |
| Methadone | 500,000 | Negative | No | Positive | No | |
| Methaqualone | 100,000 | Negative | No | Positive | No | |
| Methamphetamine | 500,000 | Negative | No | Positive | No | |
| Meprobamate | 100,000 | Negative | No | Positive | No | |
| Naltrexone | 100,000 | Negative | No | Positive | No | |
| Nitrazepam | 100,000 | Negative | No | Positive | No | |
| Norbuprenorphine | 100,000 | Negative | No | Positive | No | |
| Nordiazepam | 100,000 | Negative | No | Positive | No | |
| Nortryptyline | 100,000 | Negative | No | Positive | No | |
| Norpropoxyphene | 100,000 | Negative | No | Positive | No | |
| Oxazepam | 100,000 | Negative | No | Positive | No | |
| Pentobarbital | 100,000 | Negative | No | Positive | No | |
| Phenobarbital | 100,000 | Negative | No | Positive | No | |
| Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff) | ||||||
| Concentration | -25% Cutoff | +25% Cutoff | ||||
| Compound | Tested | (1500ng/mL) | (2500ng/mL) | |||
| (ng/mL) | Result | Interference? | Result | Interference? | ||
| Pentazocine | 100,000 | Negative | No | Positive | No | |
| Phencyclidine | 100,000 | Negative | No | Positive | No | |
| Phentermine | 100,000 | Negative | No | Positive | No | |
| Phenylpropanolamine | 500,000 | Negative | No | Positive | No | |
| PMA | 100,000 | Negative | No | Positive | No | |
| (-)Pseudoephedrine | 100,000 | Negative | No | Positive | No | |
| (+)Pseudoephedrine | 100,000 | Negative | No | Positive | No | |
| Phenytoin | 100,000 | Negative | No | Positive | No | |
| Protryptyline | 100,000 | Negative | No | Positive | No | |
| Ranitidine | 100,000 | Negative | No | Positive | No | |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No | |
| Secobarbital | 100,000 | Negative | No | Positive | No | |
| Sufentanil | 100,000 | Negative | No | Positive | No | |
| Temazepam | 100,000 | Negative | No | Positive | No | |
| 11-nor-9 carboxy THC | 100,000 | Negative | No | Positive | No | |
| Tramadol | 100,000 | Negative | No | Positive | No | |
| Trimipramine | 100,000 | Negative | No | Positive | No | |
| Venlafaxine | 100,000 | Negative | No | Positive | No |
{15}------------------------------------------------
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{16}------------------------------------------------
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c. The following is a summary table of the endogenous compounds results for the 300ng/mL cutoff:
| Table 16 - Endogenous Compounds (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Acetone | 1.0 g/dL | Negative | No | Positive | No |
| Ascorbic Acid | 1.5 g/dL | Negative | No | Positive | No |
| Bilirubin | 0.002 g/dL | Negative | No | Positive | No |
| Creatinine | 0.5 g/dL | Negative | No | Positive | No |
| Ethanol | 1.0 g/dL | Negative | No | Positive | No |
| Galactose | 0.01 g/dL | Negative | No | Positive | No |
| y-Globulin | 0.5 g/dL | Negative | No | Positive | No |
| Glucose | 2.0 g/dL | Negative | No | Positive | No |
| Hemoglobin | 0.300 g/dL | Negative | No | Positive | No |
| Human Serum Albumin | 0.5 g/dL | Negative | No | Positive | No |
| Oxalic Acid | 0.1 g/dL | Negative | No | Positive | No |
| Riboflavin | 0.0075 g/dL | Negative | No | Negative | Yes |
| Sodium Azide | 1% w/v | Negative | No | Positive | No |
| Sodium Chloride | 6.0 g/dL | Negative | No | Positive | No |
| Sodium Fluoride | 1% w/v | Negative | No | Positive | No |
| Urea | 6.0 g/dL | Negative | No | Positive | No |
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d.Riboflavin interferes with the assay and can cause a falsely low test result. This limitation has been added to the labeling regarding this compound.
- e. The following is a summary table of the endogenous compounds results for the 2000ng/mL cutoff:
| Table 17 - Endogenous Compounds (for 2000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(1500ng/mL) | +25% Cutoff(2500ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Acetone | 1.0 g/dL | Negative | No | Positive | No |
| Ascorbic Acid | 1.5 g/dL | Negative | No | Positive | No |
| Bilirubin | 0.002 g/dL | Negative | No | Positive | No |
| Creatinine | 0.5 g/dL | Negative | No | Positive | No |
| Ethanol | 1.0 g/dL | Negative | No | Positive | No |
| Galactose | 0.01 g/dL | Negative | No | Positive | No |
| y-Globulin | 0.5 g/dL | Negative | No | Positive | No |
| Glucose | 2.0 g/dL | Negative | No | Positive | No |
| Hemoglobin | 0.300 g/dL | Negative | No | Positive | No |
| Human Serum Albumin | 0.5 g/dL | Negative | No | Positive | No |
| Oxalic Acid | 0.1 g/dL | Negative | No | Positive | No |
| Riboflavin | 0.0075 g/dL | Negative | No | Positive | No |
| Sodium Azide | 1% w/v | Negative | No | Positive | No |
| Sodium Chloride | 6.0 g/dL | Negative | No | Positive | No |
| Sodium Fluoride | 1% w/v | Negative | No | Positive | No |
| Urea | 6.0 g/dL | Negative | No | Positive | No |
f. The following is a summary table of the Boric Acid for the 300ng/mL cutoff results:
| Table 18 - Boric Acid (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Boric Acid | 1% w/v | Negative | No | Negative | Yes |
g. The following is a summary table of the Boric Acid for the 2000ng/mL cutoff results:
| Table 19- Boric Acid (for 2000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | -25% Cutoff (1500ng/mL) | +25% Cutoff (2500ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| Boric Acid | 1% w/v | Negative | No | Negative | Yes |
h.Boric Acid interferes with the assay and can cause a falsely low test result. This limitation has been added to the labeling regarding this compound.
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| Table 20 - Effect of pH (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| -25% Cutoff | +25% Cutoff | ||||
| Test Parameter | Value | (225ng/mL) | (375ng/mL) | ||
| Result | Interference? | Result | Interference? | ||
| pH | 3.0 | Negative | No | Positive | No |
| pH | 4.0 | Negative | No | Positive | No |
| pH | 5.0 | Negative | No | Positive | No |
| pH | 6.0 | Negative | No | Positive | No |
| pH | 7.0 | Negative | No | Positive | No |
| pH | 8.0 | Negative | No | Positive | No |
| pH | 9.0 | Negative | No | Positive | No |
| pH | 10.0 | Negative | No | Positive | No |
| pH | 11.0 | Negative | No | Positive | No |
i. The following is a summary table of the effect of pH results for the 300ng/mL cutoff:
- j. The following is a summary table of the effect of the pH results for the 2000ng/mL cutoff:
| Table 21 - Effect of pH (for 2000ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| -25% Cutoff(1500ng/mL) | +25% Cutoff(2500ng/mL) | ||||
| Test Parameter | Value | Result | Interference? | Result | Interference? |
| pH | 3.0 | Negative | No | Positive | No |
| pH | 4.0 | Negative | No | Positive | No |
| pH | 5.0 | Negative | No | Positive | No |
| pH | 6.0 | Negative | No | Positive | No |
| pH | 7.0 | Negative | No | Positive | No |
| pH | 8.0 | Negative | No | Positive | No |
| pH | 9.0 | Negative | No | Positive | No |
| pH | 10.0 | Negative | No | Positive | No |
| pH | 11.0 | Negative | No | Positive | No |
k.The following is a summary table of the effect of specific gravity result for the 300ng/mL cutoff:
| Table 22 - Effect of Specific Gravity (for 300ng/mL cutoff) | |||||
|---|---|---|---|---|---|
| -25% Cutoff(225ng/mL) | +25% Cutoff(375ng/mL) | ||||
| Test Parameter | Value | Result | Interference? | Result | Interference? |
| Specific Gravity | 1.000 | Negative | No | Positive | No |
| Specific Gravity | 1.002 | Negative | No | Positive | No |
| Specific Gravity | 1.005 | Negative | No | Positive | No |
| Specific Gravity | 1.010 | Negative | No | Positive | No |
| Specific Gravity | 1.015 | Negative | No | Positive | No |
| Specific Gravity | 1.020 | Negative | No | Positive | No |
| Specific Gravity | 1.025 | Negative | No | Positive | No |
| Specific Gravity | 1.030 | Negative | No | Positive | No |
T
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| Test Parameter | Value | -25% Cutoff(1500ng/mL) | +25% Cutoff(2500ng/mL) | ||
|---|---|---|---|---|---|
| Result | Interference? | Result | Interference? | ||
| Specific Gravity | 1.000 | Negative | No | Positive | No |
| Specific Gravity | 1.002 | Negative | No | Positive | No |
| Specific Gravity | 1.005 | Negative | No | Positive | No |
| Specific Gravity | 1.010 | Negative | No | Positive | No |
| Specific Gravity | 1.015 | Negative | No | Positive | No |
| Specific Gravity | 1.020 | Negative | No | Positive | No |
| Specific Gravity | 1.025 | Negative | No | Positive | No |
| Specific Gravity | 1.030 | Negative | No | Positive | No |
-
- The following is a summary table of the effect of specific gravity result for the 2000ng/mI , cutoff-
-
- Linearity/ Recovery A drug free urine pool was spiked with a high concentration of the target analyte as high value specimen. Additional pools were made by serially diluting the high value specimen. The study verified assay linearity in the semi-quantitative mode. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The following is a summary table of the linearity/recovery for the 300ng/mL cutoff:
| Table 24 - Linearity/ Recovery – 300ng/mL | ||
|---|---|---|
| Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
| 100 | 91.6 | 91.6 |
| 200 | 203.7 | 101.8 |
| 300 | 292.8 | 97.6 |
| 400 | 410.1 | 102.5 |
| 500 | 488.1 | 97.6 |
| 600 | 651.1 | 108.5 |
| 700 | 759.4 | 108.5 |
| 800 | 840.6 | 105.1 |
| 900 | 906.5 | 100.7 |
| 1000 | 1024.1 | 102.4 |
| 1100 | 1069.9 | 97.3 |
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| Table 25 - Linearity/ Recovery – 2000ng/mL | ||
|---|---|---|
| Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
| 600 | 635.0 | 105.8 |
| 1200 | 1295.2 | 107.9 |
| 1800 | 1750.9 | 97.3 |
| 2000 | 2079.0 | 104.0 |
| 2400 | 2231.1 | 93.0 |
| 3000 | 3142.9 | 104.8 |
| 3600 | 3852.7 | 107.0 |
| 4200 | 4465.4 | 106.3 |
| 4800 | 5101.8 | 106.3 |
| 5400 | 5789.0 | 107.2 |
| 6000 | 5972.3 | 99.5 |
| 6600 | 6637.7 | 100.6 |
- b. The following is a summary table of the linearity/recovery for the 2000ng/mL cutoff.
- న్. Method Comparison - Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry. The instrument used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry.
- a. The following is a comparison table of qualitative assay performance for the 300ng/mL cutoff:
- Table 26 Method Comparison (for 300ng/mL cutoff) Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 1 |
| (-) | 0 | 39 |
b. The following is a summary table of qualitative assay performance for the 300ng/mL cutoff:
| Table 27 - Assay Performance verified by LC/MS – 300ng/mL Cutoff – Qualitative | |||||
|---|---|---|---|---|---|
| Opiates Concentration | Agreement(%) | ||||
| Type | < 150ng/mL | 150 ~ 299 ng/mL | 300 ~ 450 ng/mL | > 450 ng/mL | |
| Qualitative/Positive | 0 | 1 | 5 | 35 | 98% |
| Qualitative/Negative | 36 | 3 | 0 | 0 | 100% |
c. The following is a summary table of qualitative discordant results for the 300ng/mL cutoff
| Table 28 - Discordant Result Summary – 300ng/mL Cutoff – Qualitative | ||
|---|---|---|
| Qualitative Results300ng Cutoff | LC/MS Confirmation | |
| Test Device | Qualitative | Total Opiate Concentration (ng/mL) |
| Positive | Negative | 200 |
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- d. The following is a comparison table of qualitative assay performance for the 2000ng/mL cutoff:
Table 29 - Method Comparison (for 2000ng/mL cutoff) - Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| TestDevice | (-) | 0 | 40 |
e. The following is a summary table of qualitative assay performance for the 2000ng/mL cutoff:
| Table 30 - Assay Performance verified by LC/MS – 2000ng/mL Cutoff - Qualitative | |||||
|---|---|---|---|---|---|
| Type | Opiates Concentration | Agreement (%) | |||
| <1000ng/mL | 1000~1999ng/mL | 2000~3000ng/mL | >3000ng/mL | ||
| Qualitative/Positive | 0 | 0 | 5 | 35 | 100% |
| Qualitative/Negative | 36 | 4 | 0 | 0 | 100% |
f. The following is a comparison table of semi-quantitative assay performance for 300ng/mL:
Table 31 - Method Comparison (for 300ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| TestDevice | (-) | 0 | 40 |
g. The following is a summary table of semi-quantitative assay performance for the 300ng/mL cutoff:
| Table 32 - Assay Performance verified by LC/MS – 300ng/mL Cutoff – Semi-Quantitative | |||||
|---|---|---|---|---|---|
| Type | Opiates Concentration | Agreement(%) | |||
| < 150ng/mL | 150 ~ 299 ng/mL | 300 ~ 450 ng/mL | > 450 ng/mL | ||
| Semi-Quantitative/Positive | 0 | 0 | 5 | 35 | 100% |
| Semi-Quantitative /Negative | 36 | 4 | 0 | 0 | 100% |
h. The following is a comparison table of semi-quantitative assay
performance for the 2000ng/mL cutoff:
Table 33 - Method Comparison (for 2000ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| TestDevice | (+) | 40 | 0 |
| (-) | 0 | 40 |
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- i. The following is a summary table of semi-quantitative assay performance for the 2000ng/mL cutoff:
| Table 34 - Assay Performance verified by LC/MS – 2000ng/mL Cutoff – Semi-Quantitative | |||||
|---|---|---|---|---|---|
| Type | Opiates Concentration | Agreement (%) | |||
| <1000ng/mL | 1000~1999ng/mL | 2000~3000ng/mL | >3000ng/mL | ||
| Semi-Quantitative/Positive | 0 | 0 | 5 | 35 | 100% |
| Semi-Quantitative /Negative | 36 | 4 | 0 | 0 | 100% |
6. Stability -
- a. A closed accelerated stability study was performed on reagents at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year for reagents. The instruments used for this test was a Beckman Coulter AU 400e.
- b. An open/on-board stability study was performed on reagents to establish expiration dating when reagents are opened and stored on board the instrument at 2℃ to 8℃. The stability study supported an initial open vial expiration date of 28 days. The instrument used for this test was a Beckman Coulter AU 400e.
- c. Real time stability studies are ongoing
-
- Calibrator and Control Analytical Performance Immunalysis Opiates Urine Calibrators 300
- a. Opiates Calibrator Traceability all components of the calibrators have been traced to a commercially available standard solution.
- b. Opiates Calibrator Closed Vial Stability An accelerated closed vial stability study was performed at 25°C to establish the initial 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) for Morphine 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. Opiates Calibrator Open Vial Stability An accelerated open vial stability study was performed at 5℃ to establish the initial expiration dating. The stability study supported an initial 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) for Morphine were within specifications for Day 0, 19, 26, 33, 41, and 60. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- d. Opiates Calibrator Value Assignment Calibrators are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrators are adjusted and re-tested. Values
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are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
-
- Calibrator and Control Analytical Performance Immunalysis Multi-Drug Controls
- a. Multi-Drug Control Traceability all components of the controls have been traced to a commercially available standard solution.
- b. Multi-Drug Control Closed Vial Stability An accelerated closed vial stability study was performed at 25℃ to establish the initial 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 control levels (Low Control 1 and 2 and High Control 1 and 2) for Benzoylegonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam 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. Multi-Drug Control Open Vial Stability An open vial stability study was performed at 5℃ to establish the initial expiration dating. The stability study supported an initial 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 control levels (Low Control 1 and 2 and High Control 1 and 2) for Benzovlegonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam were within specifications for Day 0, 19, 26, 33, 41, and 60. This stability study was performed to establish initial expiration dating.
- d. Multi-Drug Control Value Assignment Controls are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the controls are adjusted and re-tested. Values are assigned to the controls once the mass spectrometry results are within the acceptable ranges.
-
- Calibrator Analytical Performance Immunalysis Opiates Urine Calibrators 2000
- a. Opiates Urine Calibrators Traceability all components of the calibrators have been traced to a commercially available standard solution.
- b. Opiates Urine Calibrators Closed Vial Stability An accelerated stability study was performed at 25°C to establish the initial 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) for Morphine 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. Opiates Urine Calibrators Open Vial Stability A stability study was performed at 5℃ to establish the initial expiration dating. The stability study supported an initial 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) for Morphine were within specifications for Day 0. 19. 26. 33. 41.
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and 60. This stability study was performed to establish initial expiration dating.
- d. Opiates Urine Calibrators Value Assignment Calibrators are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrators is adjusted and retested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
- I. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Opiates Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.
§ 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).