(55 days)
The Emit® Calibrator B Level 1 and Calibrator B Level 2 are used in the calibration of the Emite d.a.u.™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/ml cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphen. A caws. The Emit Calibrator B Level 1 and Calibrator B Level 2 are also used in the calibration of the Emite II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaquelone, Opiates 300/2000, and Propoxyphene Assays.
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 manufacture for commercial distribution a modified Emit® Calibrator B Level 1 (cutoff) and a modified Emit® Calibrator B Level 2 (high) used in the calibration of the Emit® d.a.u. ™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphene Assays. Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are also used in the calibration of the Emit® II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaqualone, Opiates 300/2000, and Propoxyphene Assays.
The modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are substantially equivalent to the currently marketed Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) (K912729) with regard to intended use and overall performance characteristics. The most significant difference between the modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) is the addition of morphine at 2000 ng/mL in the Calibrator B Level 1 (cutoff) and morphine at 4000 ng/mL in the Calibrator B Level 2 (high).
The modified Calibrators B contain the following drug concentrations:
| Level 1(ng/mL) | Level 2(ng/mL) | |
|---|---|---|
| Benzoylecgonine | 150 | 3000 |
| d-Amphetamine | 300 | 2000 |
| Methadone | 300 | 1000 |
| Methaqualone | 300 | 1500 |
| Morphine | 2000 | 4000 |
| Oxazepam | 300 | 1000 |
| Propoxyphene | 300 | 1000 |
| Secobarbital | 300 | 1000 |
This document describes the equivalence of a modified calibrator device (Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high)) to a previously marketed device (K912729). It does not describe a study proving a device meets acceptance criteria related to a general medical device or AI system. Instead, it demonstrates the substantial equivalence of a modified calibrator in the context of drug assays.
Therefore, many of the requested fields are not applicable to this type of submission. However, I can extract the relevant information and explain why other fields are not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of accuracy, precision, or other performance metrics usually seen for diagnostic devices. Instead, the "acceptance criteria" for this submission appear to be the demonstration of substantial equivalence to the predicate device in terms of intended use and overall performance characteristics. The key performance characteristic mentioned is the composition of the calibrator.
| Acceptance Criterion (implicitly) | Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent |
| Overall Performance Characteristics | Substantially equivalent |
| Drug Concentrations | Modified, but within context of equivalence for morphine inclusion |
The key modification and reported performance are the new drug concentrations for the modified calibrators. The performance is that these new calibrators will function equivalently for their intended use in the listed assays.
| Level 1 (ng/mL) | Level 2 (ng/mL) | Predicate Comparison (Implicit) | |
|---|---|---|---|
| Benzoylecgonine | 150 | 3000 | Unchanged (implied) |
| d-Amphetamine | 300 | 2000 | Unchanged (implied) |
| Methadone | 300 | 1000 | Unchanged (implied) |
| Methaqualone | 300 | 1500 | Unchanged (implied) |
| Morphine | 2000 | 4000 | Added component |
| Oxazepam | 300 | 1000 | Unchanged (implied) |
| Propoxyphene | 300 | 1000 | Unchanged (implied) |
| Secobarbital | 300 | 1000 | Unchanged (implied) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document describes the composition change of a calibrator, not a study involving a test set of patient samples.
- Data Provenance: Not applicable. The "study" here is a submission demonstrating equivalence. No specific patient data or retrospective/prospective studies are detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for calibrators is their manufactured concentration, not an expert-derived diagnosis.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No. This is not a diagnostic device involving human readers or interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This product is a chemical calibrator; it does not involve algorithms or human-in-the-loop performance in the sense of AI. Its performance is related to its chemical composition and stability.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for a calibrator is its known, manufactured chemical concentrations of the listed substances. This is established through analytical chemistry and quality control during the manufacturing process.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable.
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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters, which appears to be 'K971600'. The characters are written in a simple, somewhat stylized manner, with the numbers being more rounded. A horizontal line underlines the entire sequence, possibly indicating that it is a label or identifier.
Image /page/0/Picture/1 description: The image shows a logo with the word "BEHRING" in bold, uppercase letters. Below the word, there is a signature that appears to read "L. Behring". The logo is contained within a rectangular border.
JUN 2 5 1997
3403 Yerba Buena Road San Jose. CA 95135
SUMMARY OF SAFETY AND EFFECTIVENESS Emit® Calibrator B Level 1 (cutoff) Emit® Calibrator B Level 2 (high)
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 manufacture for commercial distribution a modified Emit® Calibrator B Level 1 (cutoff) and a modified Emit® Calibrator B Level 2 (high) used in the calibration of the Emit® d.a.u. ™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphene Assays. Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are also used in the calibration of the Emit® II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaqualone, Opiates 300/2000, and Propoxyphene Assays.
The modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are substantially equivalent to the currently marketed Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) (K912729) with regard to intended use and overall performance characteristics. The most significant difference between the modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) is the addition of morphine at 2000 ng/mL in the Calibrator B Level 1 (cutoff) and morphine at 4000 ng/mL in the Calibrator B Level 2 (high).
The modified Calibrators B contain the following drug concentrations:
| Level 1(ng/mL) | Level 2(ng/mL) | |
|---|---|---|
| Benzoylecgonine | 150 | 3000 |
| d-Amphetamine | 300 | 2000 |
| Methadone | 300 | 1000 |
| Methaqualone | 300 | 1500 |
| Morphine | 2000 | 4000 |
| Oxazepam | 300 | 1000 |
| Propoxyphene | 300 | 1000 |
| Secobarbital | 300 | 1000 |
In conclusion, Behring Diagnostics Inc. considers the modified Emit® Calibrator B Level 1 (cutoff) and the modified Emit® Calibrator B Level 2 (high) to be substantially equivalent to the existing Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high).
Syva® and Behring diagnostic products
ﻨﻤﺴﯿﺴﻪ
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 25 097
David Kolesar Administrator, Requlatory Affairs Behring Diagnostics ....................... P.O. Box 49013 San Jose, California 95161-9013
Re: K971600 Emit® Calibrator B Level 1 (Cutoff)/Emit® Calibrator B Level 2 (High) Requlatory Class: II Product Code: DKB 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 The general controls provisions of the Act 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 Requlations, 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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Page 2
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 t (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 leqally 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 Sitman
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® Calibrator B Level 1 (cuttof)
Emit® Calibrator B Level 2 (high)
Indications For Use:
The Emit® Calibrator B Level 1 and Calibrator B Level 2 are used in the calibration of the Emite d.a.u.™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/ml cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphen. A caws. The Emit Calibrator B Level 1 and Calibrator B Level 2 are also used in the calibration of the Emite II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaquelone, Opiates 300/2000, and Propoxyphene Assays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Clinical Laboratory I. svices 510(k) Number .
Prescription Use_
OR
Over-The-Counter Use_
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K97/600
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.