(7 days)
Not Found
No
The document describes quality control materials for drug testing and does not mention any AI or ML components.
No
Explanation: This device is a quality control material used for monitoring the performance of drug tests, not for treating any medical condition.
No
This device is identified as a "control" used for "monitoring the quality control" of reagents. It is not directly used to diagnose a patient's condition but rather to ensure the accuracy of diagnostic tests.
No
The device description clearly states it is a "Urine Control," which is a physical substance used for quality control in laboratory testing, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls are used "for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory." This indicates that the device is used in vitro (outside the body) to analyze samples (urine) for diagnostic purposes (monitoring the performance of tests for drugs of abuse).
- Device Description: The description reinforces this by stating they are used "for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine reagents in the clinical laboratory." This further confirms its role in the diagnostic process.
- Clinical Laboratory Setting: The intended user/care setting is the "clinical laboratory," which is where IVD tests are typically performed.
- Predicate Device: The predicate device listed (K920477 Drugs of Abuse Urine Calibrators) is also an IVD, which supports the classification of this device as an IVD.
While the device itself is a control material and not a test that directly diagnoses a condition, it is an essential component used in vitro within the diagnostic process to ensure the accuracy and reliability of the drug of abuse tests. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems DAT Low and High Urine Controls 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.
Product codes
DIF
Device Description
The SYNCHRON® Systems DAT Low and High Urine Controls 1 are used for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine reagents in the clinical laboratory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stress stability studies of the DAT Low and High Unne Controls 1 support the Beckman stability claim of 18 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.
0
OCT 28 1998
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved lines inside, resembling a stylized eye or a symbol of interconnectedness. To the right of the symbol, the words "BECKMAN COULTER" are written in bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
K 983709
Summary of Safety & Effectiven SYNCHRON® Systems DAT Low and High Urine Controls 1
Submitted By: 1.0
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
Date Submitted: 2.0
October 19, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems DAT Low and High Urine Controls 1
Classification Name 3.2
Control Material, Clinical Toxicology (21 CFR §862.3280)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|-----------------------------------------------------------|-------------------------------------|--------------------------------|------------------|
| SYNCHRON® Systems
DAT Low and High
Urine Controls 1 | Drugs of Abuse Urine
Calibrators | Diagnostic Reagents,
Inc. * | K920477 |
*Diagnostic Regents, Inc. Mountain View, CA
5.0 Description:
The SYNCHRON® Systems DAT Low and High Urine Controls 1 are used for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine reagents in the clinical laboratory.
1
5.0 Intended Use:
.
The SYNCHRON® Systems DAT Low and High Urine Controls 1. in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.
7.0 Comparison to Predicate(s):
Identical to predicate product with Beckman Coulter, Inc. label and increased level of Opiate analyte.
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 DAT Low and High Unne Controls 1 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 requiration 21 CFR 807.92.
2
DEPARTMENT OF HEALTH & HUMAN USA
OCT 28 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., M/S W-104 Box 8000 Brea, CA 92822-8000
Re: K983709
Trade Name: SYNCHRON® Systems DAT Low and High Urine Controls 1 Regulatory Class: I Product Code: DIF Dated: October 19, 1998 Received: October 21, 1998
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 Ouality 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.
3
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 (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 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
4
page _ of _
510(k) Number (if known): Not yet assigned
Device Name: SYNCHRON® Systems DAT Low and High Urine Controls 1
Indications for Use:
The SYNCHRON® Systems DAT Low and High Urine Controls 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.
21 CFR 862.3280 Control Material, Clinical Toxicology
(a) Identification. A clinical toxicology control is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
(b) Classification. Class I.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of Clinical Labora 510(k) Number OR Over-the-Counter Use (per 21 CFR 801.109) Optional Format 1-2-96
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use U