(61 days)
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No
The document describes calibrators for an immunoassay system and does not mention any AI or ML components or functionalities.
No
The device is a calibrator for enzyme immunoassays and is used for calibration, not for treating or diagnosing a disease or condition.
Yes
Explanation: The device is a calibrator used for enzyme immunoassays on SYNCHRON Systems, which are used to measure opiate levels. Calibrators are essential components in diagnostic tests as they establish the measurement scale for the analyte, ensuring the accuracy and reliability of the diagnostic results. Without proper calibration, the results of a diagnostic test like an immunoassay would be unreliable. Therefore, while not directly performing the diagnosis, it is an indispensable part of the diagnostic process.
No
The device description clearly states it is a liquid calibrator product containing physical bottles of calibrant solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are for "calibration of Opiate 300 ng enzyme immunoassays." Calibration is a crucial step in in vitro diagnostic testing to ensure the accuracy of the assay results.
- Device Description: The description details that the calibrators are "human, urine-based, liquid calibrators" derived by adding known quantities of morphine to human urine. This indicates they are used in a laboratory setting to interact with biological samples (urine) for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K983747; SYNCHRON® Systems DAT Low and High Urine Calibrators II) which is also a calibrator for drug assays, further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
The device is used in vitro (outside the body) to calibrate an assay that measures a substance (opiates) in a biological sample (urine) for diagnostic purposes (determining the presence and concentration of opiates). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Beckman Coulter OP 300 Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng (Part No. 475024) enzyme immunoassays.
Product codes
DLJ
Device Description
The SYNCHRON® Systems OP 300 Low and High Urine Calibrators are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng enzyme immunoassays. This product contains a 5.0 mL bottle of the Low Urine Calibrator and a 5.0 mL bottle of the High Urine Calibrator. The storage temperature for the calibrators is +2°C to +8°C.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 862.3200 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.
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Image /page/0/Picture/1 description: The image shows the text 'K993022' in a handwritten style. The text appears to be a code or identifier, with a combination of letters and numbers. The characters are bold and slightly slanted, giving the impression of quick handwriting. The background is plain white, which makes the text stand out.
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling a rounded shape with two curved lines running through it. To the right of the symbol, the words "BECKMAN" are stacked above the word "COULTER" in a bold, sans-serif font. The logo is black and white.
Summary of Safety and Effectiveness SYNCHRON® Systems OP 300 Low and High Urine Calibrators
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 Calibrators
3.2 Classification Name
Clinical Toxicology Calibrator (21 CFR § 862.3200)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------------------------------|------------------------------------------------------------------|-----------------------|------------------|
| SYNCHRON® Systems
OP 300 Low and High
Urine Calibrators | SYNCHRON®
Systems DAT Low
and High Urine
Calibrators II | Beckman Coulter, Inc. | K983747 |
5.0 Description:
The SYNCHRON® Systems OP 300 Low and High Urine Calibrators are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng enzyme immunoassays. This product contains a 5.0 mL bottle of the Low Urine Calibrator and a 5.0 mL bottle of the High Urine Calibrator. The storage temperature for the calibrators is +2°C to +8°C.
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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 1999
Ms. Gail Lefebvre Associate Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., M/S W-104 Brea. California 92822-8000
- Re: K993022
Trade Name: SYNCHRON® Systems OP 300 Low and High Urine Calibrators Regulatory Class: II Product Code: DLJ 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 OS 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 Sutman
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
3
Page of of
510(k) Number (if known): K993022
Device Name: SYNCHRON® Systems OP 300 Low and High Urine Calibrators
Indications for Use:
The Beckman Coulter OP 300 Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng (Part No. 475024) enzyme immunoassays.
Clinical Significance:
The OP Low and High Urine Calibrators are ready-to-use human, urine-based. liquid calibrators. 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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Labora
ces
510(k) Number K993022
(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