(35 days)
K9944074
Not Found
No
The summary describes a reagent for a laboratory analyzer and does not mention any AI or ML components or capabilities.
No
The device is described as a reagent intended for the qualitative determination of methadone in human urine, which is a diagnostic function, not a therapeutic one.
Yes
This device is intended for the qualitative determination of methadone in human urine, which is a diagnostic test to identify the presence of a substance.
No
The device is a reagent intended for use with a SYNCHRON System, which is a hardware instrument for laboratory testing. The 510(k) describes a chemical reagent, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of methadone in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to diagnose or provide information about a physiological state (presence of methadone).
- Device Description: The device description reiterates the intended use, confirming it's for testing human urine.
- Predicate Device: The mention of a predicate device (K9944074; SYNCHRON Systems Methadone) which is also an IVD, further supports that this device falls under the IVD category.
The key characteristic of an IVD is that it's used to examine specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The SYNCHRON Methadone Reagent, in conjunction with the SYNCHRON CX Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.
The Beckman Methadone assay provides a rapid screening procedure for determining the presence of methadone in urine. The test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatograph/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical Consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DJR
Device Description
The SYNCHRON Methadone Reagent, in conjunction with the SYNCHRON CX Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the new SYNCHRON Methadone formulation vs the current formulation . Stress stability studies of the Methadone reagent support the Beckman stability claim of 12 months at 4°C and 60 days on a SYNCHRON instrument.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K9944074
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
SEP 2 2
イ
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Methadone (METD) Reagent Summary of Safety & Effectiveness
Summary of Safety & Effectiveness Beckman SYNCHRON Systems Methadone Reagent
1.0 Submitted By:
Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457
2.0 Date Submitted:
14 August 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Methadone Reagent
3.2 Classification Name
Methadone Test System (21 CFR § 862.3620)
4.0 Predicate Device(s):
| BECKMAN Reagent | Predicate | Predicate Company | Docket Number |
|---|---|---|---|
| SYNCHRON Systems | |||
| Methadone | SYNCHRON Systems | ||
| Methadone | Beckman | ||
| Instruments, Inc. | K9944074 |
5.0 Description:
The SYNCHRON Methadone Reagent, in conjunction with the SYNCHRON CX Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.
1
Intended Use: 6.0
The Beckman Methadone assay provides a rapid screening procedure for determining the presence of methadone in urine. The test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatograph/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical Consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON | ||
| Systems Methadone | ||
| (METD) Reagent | Intended use | Same as the predicate |
| Chemical Reaction | Same principle as the predicate | |
| Calibration | Same as the predicate | |
| Reagent Kit Configuration | Same as the predicate | |
| Product Part Number | Same as the predicate |
SIMILARITIES to the PREDICATE
DIFFERENCES from the PREDICATE
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON | ||
| Systems | ||
| Methadone | ||
| (METD) Reagent | Specificity of monoclonal | |
| antibody | Current Formulation: | |
| Specific to both methadone and LAMM | ||
| New Formulation: | ||
| Specific only to methadone |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the new SYNCHRON Methadone formulation vs the current formulation . Stress stability studies of the Methadone reagent support the Beckman stability claim of 12 months at 4°C and 60 days on a SYNCHRON instrument.
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/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font.
SEP 2 2 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92622-8000
K973069/S1 Re : SYNCHRON® Systems Methadone Reagent Requlatory Class: II Product Code: DJR September 8, 1997 Dated: September 10, 1997 Received:
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 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chill ou)) enize dover mine 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 aciding 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/dsmamain.html".
Sincerely yours,
Steven Litman
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 of
510(k) Number (if known): Not yet assigned
SYNCHRON® Systems Methadone Reagent Device Name:
Indications for Use:
The Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 nq/mL, on SYNCHRON Systems.
21 CFR 862.3620 Methadone Test System
(a) Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.
(b) Classification. Class II.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Carl Benam, L. Alfred Montgomery
(Division Sign-Off) O
Division of Clinical Laboratory Devices
510(k) Number K973069
Prescription Use
(per 21 CFR 801.109)
Over-the-Counter Use Optional Format 1-2-96