(50 days)
The SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.
The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are readyto-use human urine-based calibrator materials.
The provided document is a 510(k) summary for the SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study demonstrating the device meets those criteria in the way a performance study for an AI/ML medical device would.
This document pertains to a calibrator device, which is a reference material used to ensure the accuracy of other diagnostic tests. The performance evaluation for such a device focuses on its stability and its ability to function as intended for calibration, rather than on diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI/ML devices.
Therefore, many of the requested elements are not applicable to this type of device and the information provided in the 510(k) summary. I will answer as best as possible, indicating when information is not available or not applicable.
Description of Acceptance Criteria and Study Proving Device Meets Criteria
The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are ready-to-use human urine-based calibrator materials intended for use with SYNCHRON Systems and SYNCHRON Reagents to calibrate enzyme immunoassays for several drugs. The primary performance criteria for a calibrator are its stability and its ability to establish accurate points of reference for the assays. The study performed focused on stress stability to support the claimed shelf-life.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a calibrator device, explicit detailed "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity thresholds) are not typically defined in the same way as for a diagnostic test itself. Instead, the "acceptance criteria" for a calibrator revolve around its stability and its ability to consistently produce expected calibration values when used in conjunction with the assays it is designed for.
| Acceptance Criteria (Implied for Calibrators) | Reported Device Performance |
|---|---|
| Stability: Maintain intended chemical properties and concentration for a specified shelf-life. | Stress stability studies of the DAT Multi-Drug Low and High Urine Calibrators were conducted. These studies support the Beckman stability claim of 12 months. This indicates that the calibrators maintained their critical performance characteristics (e.g., concentration of target analytes) under accelerated or real-time conditions for at least 12 months. The specific measurements or thresholds for "maintenance" are not detailed in this summary, but would typically involve analytical precision and accuracy within defined limits. |
| Substantial Equivalence: Function comparably to a legally marketed predicate device. | The device was found to be "Identical to predicate product but labeled for Beckman Coulter, Inc." and was determined to be substantially equivalent to toxicology calibrators already in commercial distribution (Predicate: Multi-Drug Urine Calibrators from Diagnostic Reagents, Inc., K983159). This implies that its performance, when used as a calibrator, is expected to be comparable to that of the predicate. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: The document does not specify the sample size used for the stress stability studies. It only mentions "stress stability studies." For calibrators, this typically involves multiple lots of the calibrator material, subjected to various temperature and storage conditions over time.
- Data provenance: Not explicitly stated, but assumed to be generated internally by Beckman Coulter, Inc. as part of their product development and validation process. The country of origin for the data is implicitly the USA (company location). The studies are prospective in nature, as they assess stability over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a calibrator, "ground truth" is defined by the known concentrations of the analytes within the calibrator material, established through validated analytical methods, not by expert consensus or interpretation.
4. Adjudication method for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which is not the case for calibrator stability studies.
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 device is a calibrator, not an AI/ML diagnostic tool, and involves no human reader interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a calibrator, not an algorithm or AI.
7. The type of ground truth used
The "ground truth" for a calibrator is the manufactured and verified concentration of each drug substance within the calibrator material. This is established through rigorous analytical testing during manufacturing and quality control.
8. The sample size for the training set
Not applicable. The concept of a "training set" is relevant for AI/ML models. For a calibrator, the manufacturing process and quality control define the product, not a training algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with a white wave-like design inside. To the right of the circle are the words "BECKMAN" in a larger, bolder font, stacked above the word "COULTER" in a slightly smaller font. The logo is simple and modern, with a focus on the company name.
Summary of Safety & Effectiveness SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators
1.0 Submitted By:
Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted:
November 16, 1999
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators
3.2 Classification Name
Calibrator, Drug Mixture (21 CFR §862.3200)
4.0 Predicate Device(s):
| SYNCHRON SystemsReagent | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| SYNCHRON® SystemsMulti-Drug DAT Lowand High UrineCalibrators | Multi-Drug UrineCalibrators | Diagnostic Reagents,Inc.* | K983159 |
*Diagnostic Reagents, Inc. Sunnyvale, CA
5.0 Description:
The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are readyto-use human urine-based calibrator materials.
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
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5.0 Intended Use:
The SYNCHRON® Systems DAT Multi-Druq Low and High Urine Calibrators, in coniunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.
7.0 Comparison to Predicate(s):
Identical to predicate product but labeled for Beckman Coulter, Inc.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to toxicology calibrators already in commercial distribution. Stress stability studies of the DAT Multi-Drug Low and High Urine Calibrators support the Beckman stability claim of 12 months.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing requiration 21 CFR 807.92.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with two snakes entwined around it, topped with a pair of wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
'JAN 1 1 2000
Ms. Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104 Box 8000 Brea, California 92822-8000
Re: K993954
Trade Name: SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators Regulatory Class: II Product Code: DKB Dated: November 16, 1999 Received: November 22, 1999
Dear Ms. Stockert:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Not-yet-assigned
Device Name: SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators
Indications for Use:
The SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.
21 CFR 862.3200 Calibrators, Drug Mixture
(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.
(b) Classification. Class II.
Sean Cooper
Division Sign-Off) Division of Clinical Laboratory Devices 993954 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
§ 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.