(55 days)
The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.
The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff, The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics.
Here's an analysis of the provided text regarding the Emit® II Opiates 300/2000 Assay, broken down into the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes qualitative and semi-quantitative performance, with different metrics for each.
| Metric (Acceptance Criteria Implied by "Acceptable") | 300 ng/mL Cutoff (Qualitative) | 2000 ng/mL Cutoff (Qualitative) | 300 ng/mL Cutoff (Semi-Quantitative) | 2000 ng/mL Cutoff (Semi-Quantitative) |
|---|---|---|---|---|
| Within-run Precision (CV%) | 0.49 - 0.79% | 0.66 - 0.99% | 2.66 - 4.30% (as concentrations) | 2.49 - 3.33% (as concentrations) |
| Total Precision (CV%) | 0.66 - 0.85% | 0.78 - 1.11% | 3.63 - 5.66% (as concentrations) | 3.74 - 4.65% (as concentrations) |
| Agreement with Predicate Method | 99.4% | 99.4% | Not specified (implied excellent agreement) | Not specified (implied excellent agreement) |
| Agreement with GC/MS Confirmation | 95.3% | 95.3% | Excellent (on basis of concentrations) | Excellent (on basis of concentrations) |
| Spiked Samples (Qualitative) | Correctly distinguished as positive relative to cutoff | Correctly distinguished as positive relative to cutoff | N/A | N/A |
| Spiked Samples (Semi-Quantitative) | N/A | N/A | Quantitated within 20% of mean GC/MS value | Quantitated within 20% of mean GC/MS value |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It mentions "spiked samples" and comparison to a "predicate method" and "GC/MS confirmation," but no specific numbers of samples or origins (e.g., retrospective/prospective, country of origin) are provided for these test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in-vitro diagnostic assay for opiate detection in urine. The ground truth is established through analytical methods (GC/MS confirmation, predicate device comparison) rather than expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established through objective analytical methods. There is no mention of human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretation-based diagnostic devices where human readers are involved. The Emit® II Opiates 300/2000 Assay is an automated in-vitro diagnostic test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance presented is standalone. The Emit® II Opiates 300/2000 Assay is an automated homogeneous enzyme immunoassay. Its performance is measured directly by analyzing urine samples, not through human interpretation or a human-in-the-loop process.
7. The Type of Ground Truth Used
The types of ground truth used are:
- Predicate device comparison: The results were compared to a previously cleared device (Emit® II Opiate Assay, K902577).
- GC/MS confirmation: Gas Chromatography/Mass Spectrometry (GC/MS) is considered the gold standard for drug confirmation in toxicology and thus serves as an objective ground truth for both qualitative and quantitative analysis.
- Spiked samples: Samples with known concentrations of opiates were prepared and tested to assess the assay's ability to correctly identify and quantify them.
8. The Sample Size for the Training Set
The document describes performance studies, but it does not specify a separate "training set" sample size. This type of in-vitro diagnostic device development typically involves analytical validation (precision, accuracy, comparison studies) rather than a machine learning "training set" in the conventional sense. The "performance studies" are essentially the validation data.
9. How the Ground Truth for the Training Set Was Established
As there isn't a "training set" in the machine learning context, this question is not fully applicable. However, the methods used to establish the "ground truth" for evaluating the device's performance (which would inform its development and validation) are the same as those listed in point 7: comparison to a predicate device, GC/MS confirmation, and known concentrations in spiked samples. These methods provide the reference standard against which the assay's accuracy is measured.
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JUN 25 1997
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3403 Yerba Buena Road P.O. Box 49031 San Jose, CA. 95161-9013
SUMMARY OF SAFETY AND EFFECTIVENESS Emit® II Opiates 300/2000Assay
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
Behring Diagnostics Inc. is submitting this Premarket Notification, 510(k) to convey our intention to commericially distribute the Emit® II Opiates 300/2000 Assay, an in vitro diagnostic reagent test kit for the qualitative and semiquantitative analysis of Opiates in human urine. The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff, The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics.
PERFORMANCE STUDIES
Qualitatively, utilizing the 300 ng/mL cutoff, the Emit® II Opiates 300/2000 Assay demonstrated acceptable within-run precision with coefficients of variation (CV%) as rates ranging from 0.49 - 0.79% and acceptable total precision with coefficients of variation (CV%) as rates ranging from 0.66 - 0.85%. Utilizing the 2000 ng/mL cutoff, the Emit® II Opiates 300/2000 Assay demonstrated acceptable withinrun precision with coefficients of variation (CV%) as rates ranging from 0.66 - 0.99% and acceptable total precision with coefficients of variation (CV%) as rates ranging from 0.78 - 1.11% The Emit® II Opiates 300/2000 Assay using the either the 300 ng/mL cutoff or the 2000 ng/mL cutoff correctly distinguished spiked samples as positive relative to its respective cutoff. Comparative analysis to the predicate method (99.4% agreement) and GC/MS confirmation (95.3% agreement) are excellent,
Semiquantitatively, utilizing the 300 ng/mL cutoff, the Emit® II Opiates 330/2000 Assay demonstrated acceptable within-run precision with coefficients of variation (CV%) as concentrations ranging from 2.66 - 4.30% and acceptable total precision with coefficients of variation (CV%) as concentrations ranging from 3.63 - 5.66%. Utilizing the 2000 ng/mL cutoff, the Emit® II Opiates 300/2000 Assay demonstrated acceptable within-run precision with coefficients of variation (CV%) as concentrations ranging from 2.49 - 3.33% and acceptable total precision with coefficients of variation (CV%) as concentrations ranging from 3.74 - 4.65%%. The Emit® II Opiates 300/2000 Assay, encompassing the either the 300 ng/mL cutoff or the 2000 ng/mL cutoff, quantitated spiked samples within 20% of the mean 3C/MS value. Comparative analysis to GC/MS on the basis of concentrations and confirmation of the Emit assay results are excellent.
n conclusion, Behring Diagnostics Inc. considers the Emit® II Opiates 300/2000 Assay to be ubstantially equivalent to the Emit® II Opiate Assay (K902577).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 25 1997
David Kolesar · Administrator, Requlatory Affairs Behring Diagnostics -P.O. Box 49013 San Jose, California 95161-9013
Re: K971596 Emit® II Opiates 300/2000 Assay Requlatory Class: II Product Code: DJG Dated: April 29, 1997 Received: May 1, 1997
Dear Mr. Kolesar:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________ Emit® II Opiates 300/2000 Assay
Indications For Use:
The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971596
§ 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).