(39 days)
No
The summary describes a chemical reagent and calibrator for a clinical chemistry analyzer, with performance evaluated through standard analytical chemistry metrics like slope, intercept, correlation coefficient, and imprecision. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML.
No.
The device is described as a reagent intended for the quantitative determination of alcohol in human serum or plasma samples, used with clinical chemistry analyzers. This indicates an in vitro diagnostic (IVD) device used for diagnostic purposes, not for providing therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the quantitative determination of alcohol in human serum or plasma samples," which is a diagnostic purpose to measure a substance in the body.
No
The device is a reagent and calibrator kit intended for use with a clinical chemistry analyzer, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of alcohol in human serum or plasma samples." This involves testing biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: It describes a "Reagent" and "Calibrator" used in conjunction with "clinical chemistry analyzers." Reagents and calibrators are common components of IVD test systems.
- Performance Studies: The performance studies describe method comparison and imprecision experiments using biological samples (implied by the "serum or plasma" in the intended use and the "mg/dL" units for alcohol concentration). These types of studies are standard for evaluating the performance of IVD tests.
- Predicate Devices: The mention of "Predicate Device(s)" with K numbers and names like "DCL Ethanol Assay" further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
The core function of the device is to analyze biological samples in vitro to provide information about a patient's health status (in this case, alcohol levels), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX20 Clinical System.
21 CFR 862.3040 Alcohol test system
(a) Identification. An alcohol test system is a device intended to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
(b) Classification. Class II.
Product codes
DIC, DMT
Device Description
The SYNCHRON Systems Alcohol (ALC) Reagent in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
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
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison studies and imprecision experiments that relate results obtained from SYNCHRON Systems Alcohol Reagent.
Method Comparison Study Results:
Reagent (Analyte): SYNCHRON Systems Alcohol (ALC) Reagent
Slope: 1.037
Intercept (mg/dL): 0.34
r: 0.9986
n: 78
Predicate Method: DCL Ethanol Assay Kit on the SYNCHRON CX Systems
Estimated Within-Run Imprecision Alcohol Reagent:
Within-Run Imprecision Default Range:
Level 1: Mean (mg/dL) 51.4, S.D. (mg/dL) 0.89, %C.V. 1.73, N 80
Level 2: Mean (mg/dL) 102.2, S.D. (mg/dL) 1.57, %C.V. 1.53, N 80
Level 3: Mean (mg/dL) 239.7, S.D. (mg/dL) 3.19, %C.V. 1.33, N 80
Within-Run Imprecision Extended Range:
Level 1: Mean (mg/dL) 287.55, S.D. (mg/dL) 3.58, %C.V. 1.24, N 20
Level 2: Mean (mg/dL) 488.63, S.D. (mg/dL) 6.08, %C.V. 1.24, N 20
Key Metrics
Method Comparison Study Results: r = 0.9986, Slope = 1.037, Intercept = 0.34 mg/dL
Estimated Within-Run Imprecision: %C.V. ranges from 1.24% to 1.73%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.
0
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness
JUN - 3 1997
Summary of Safety & Effectiveness SYNCHRON® Systems Alcohol (ALC) Reagent
Submitted By: 1.0
Maria Zeballos Scientist II, Chemistry Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-150 Brea, California 92822-8000 Telephone: (714) 961-4435 FAX: (714) 961-3740
2.0 Date Submitted:
18 April 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Alcohol (ALC) Reagent
3.2 Classification Names
Alcohol Test system (21 CFR 862.3040)
4.0 Predicate Device(s):
| SYNCHRON
Reagent | Predicate | Predicate Company | Docket
Number |
|----------------------------------------------|----------------------|-------------------------------------------------------------------------|--------------------|
| SYNCHRON
Systems Alcohol
(ALC) Reagent | DCL Ethanol
Assay | Diagnostic Chemicals
Limited (DCL),
Charlottetown, PEI,
Canada | K923783
K924733 |
1
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness
Description: 5.0
The SYNCHRON Systems Alcohol (ALC) Reagent in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
Intended Use: 6.0
The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/
Characteristic | Comments |
|----------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON
Systems Alcohol
(ALC) Reagent | Intended use | Same as DCL Ethanol Assay Kit;
determination of alcohol
concentration in serum or plasma |
| | Chemical reaction | Same as DCL Ethanol Assay Kit;
enzymatic, Alcohol
Dehydrogenase (ADH) reaction |
| | Formulation | Same as DCL Ethanol Assay Kit |
| | Measurement
method | Same as DCL Ethanol Assay Kit;
endpoint measurement at 340 nm |
| | Packaging | Same as DCL Ethanol Assay Kit;
a multi reagent kit that requires
preparation. |
| | Calibration | Same as DCL Ethanol Assay Kit;
single level aqueous calibrator |
2
SUNE INFE
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| DIFFERENCES | ||
| SYNCHRON | ||
| Systems | ||
| Alcohol (ALC) | ||
| Reagent | Range expansion | The DCL Ethanol Assay Kit |
| measures alcohol concentrations at | ||
| the initial range of 5 -250 mg/dL; | ||
| while the SYNCHRON Systems | ||
| ALC reagent measures alcohol | ||
| concentrations at the initial range of | ||
| 5 - 250 mg/dL and expanded range | ||
| of 200 - 500 mg/dL |
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison studies and imprecision experiments that relate results obtained from SYNCHRON Systems Alcohol Reagent.
Method Comparison Study Results SYNCHRON Systems Alcohol (ALC) Reagent
| Reagent
(Analyte) | Slope | Intercept
(mg/dL) | r | n | Predicate
Method |
|-------------------------------------------------|-------|----------------------|--------|----|--------------------------------------------------------------|
| SYNCHRON
Systems
Alcohol (ALC)
Reagent | 1.037 | 0.34 | 0.9986 | 78 | DCL Ethanol
Assay Kit on
the
SYNCHRON
CX Systems |
3
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness
| Sample | Mean
(mg/dL) | S.D.
(mg/dL) | %C.V. | N |
|---------------------------------------|-----------------|-----------------|-------|----|
| Within-Run Imprecision Default Range | | | | |
| Level 1 | 51.4 | 0.89 | 1.73 | 80 |
| Level 2 | 102.2 | 1.57 | 1.53 | 80 |
| Level 3 | 239.7 | 3.19 | 1.33 | 80 |
| Within-Run Imprecision Extended Range | | | | |
| Level 1 | 287.55 | 3.58 | 1.24 | 20 |
| Level 2 | 488.63 | 6.08 | 1.24 | 20 |
Estimated Within-Run Imprecision Alcohol Reagent
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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 3 1997
Sheri Hall Manager, Premarket Regulatory Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000
K971506 Re : SYNCHRON® Systems Alcohol (ALC) Reagent Requlatory Class: II Product Code: DIC, DMT Dated: April 18, 1997 Received: April 25, 1997
Dear Ms. Hall:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
5
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 atlow you to begin marketing your device as i 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 requlation (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 Gutman
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
6
510(k) Number (if known):
Device Name: SYNCHRON® Systems Alcohol (ALC) Reagent
Indications for Use:
The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
21 CFR 862.3040 Alcohol test system
(a) Identification. An alcohol test system is a device intended to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
(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
(Division Sign-on)
Division of Clinical Laboratory Devices
510(k) Number
K971506
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use Optional Format 1-2-96