(78 days)
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No
The document describes quality control materials for a laboratory system and does not mention any AI or ML components.
No
This device is described as a quality control product for monitoring the SYNCHRON Systems, not for direct diagnosis, treatment, or prevention of disease in a patient. It is used to ensure the accuracy of other tests, not as a therapeutic intervention itself.
No
Explanation: The device is described as controls for monitoring quality control in a clinical laboratory, not for diagnosing a condition in a patient.
No
The device description clearly states it is a physical product consisting of liquid controls in bottles, intended for use on SYNCHRON Systems. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the quality control for OP 300 ng in the clinical laboratory." This indicates it's used to assess the performance of a diagnostic test (the SYNCHRON Reagents for OP 300 ng) performed in vitro (outside the body) on a biological sample (urine).
- Device Description: The description confirms it's a "human, urine-based, liquid control" used for "quality control of Opiate 300 ng" on SYNCHRON Systems. This further reinforces its role in the in vitro diagnostic process.
- Care Setting: The intended user is the "clinical laboratory," which is the typical setting for performing in vitro diagnostic tests.
- Predicate Device: The predicate device listed (K983748; SYNCHRON® Systems DAT Low and High Urine Controls II) is also a quality control material for in vitro diagnostic testing (drug screening).
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. In this case, the control is used to ensure the accuracy and reliability of the diagnostic test for opiates in urine.
N/A
Intended Use / Indications for Use
The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Opiate 300 ng in the clinical laboratory.
Product codes
JJY
Device Description
The SYNCHRON® Systems OP 300 Low and High Urine Controls are intended for use on SYNCHRON Systems for the quality control of Opiate 300 ng. This product contains a 5.0 mL bottle of the Low Urine Control and a 5.0 mL bottle of the High Urine Control. The storage temperature for the calibrators is +2℃ to +8℃.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to toxicology controls already in commercial distribution. Stress stability studies of the OP 300 Low and High Urine Controls support the Beckman stability claim of 18 months.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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NOV 26 1999
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a stylized representation of three curved lines within a circle, and the company name is written in a bold, sans-serif font.
Summary of Safety and Effectiveness SYNCHRON® Systems OP 300 Low and High Urine Controls
1.0 Submitted By:
Gail Lefebvre Associate Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8503 FAX: (714) 961-4123
2.0 Date Submitted . .
September 7, 1999
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems OP 300 Low and High Urine Controls
3.2 Classification Name
Clinical Toxicology Control (21 CFR § 862.3280)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|------------------------------------------------------------|------------------------------------------------------------|-----------------------|------------------|
| SYNCHRON® Systems
OP 300 Low and High
Urine Controls | SYNCHRON® Systems
DAT Low and High
Urine Controls II | Beckman Coulter, Inc. | K983748 |
5.0 Description:
The SYNCHRON® Systems OP 300 Low and High Urine Controls are intended for use on SYNCHRON Systems for the quality control of Opiate 300 ng. This product contains a 5.0 mL bottle of the Low Urine Control and a 5.0 mL bottle of the High Urine Control. The storage temperature for the calibrators is +2℃ to +8℃.
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com
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6.0 Intended Use:
The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for OP 300 ng in the clinical laboratory.
7.0 Comparison to Predicate(s):
The opiate level between the two products is identical. Both the candidate and the predicate are human, urine-based, ready-to-use liquid calibrators with 300 ng and 1000 nq opiate (morphine) analyte added.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to toxicology controls already in commercial distribution. Stress stability studies of the OP 300 Low and High Urine Controls support the Beckman stability claim of 18 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 regulation 21 CFR 807.92.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 1999
Ms. Gail Lefebvre Associate Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 Box 8000 Brea, California 92822-8000
K993023 Re:
Trade Name: SYNCHRON® Systems OP 300 Low and High Urine Controls Regulatory Class: I Product Code: JJY Dated: September 7, 1999 Received: September 9, 1999
Dear Ms. Lefebvre:
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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): K993023
Device Name: SYNCHRON® Systems OP 300 Low and High Urine Controls
Indications for Use:
The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Opiate 300 ng in the clinical laboratory.
Clinical Significance:
The SYNCHRON® Systems OP Low and High Urine Controls are ready-to-use human, urine-based, liquid controls. They are derived by adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993023 |
| Prescription Use (per 21 CFR 801.109) | OR | Over-the-Counter Use Optional Format 1-2-96 |
|---|---|---|
| --------------------------------------- | ------------------------------------------ | --------------------------------------------- |