(57 days)
K926236/A
Not Found
No
The document describes a calibrator for clinical chemistry analyzers, which is a reagent used for calibration, not a device that processes data or makes decisions using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
This device is a calibrator for in vitro diagnostic tests, used to ensure the accuracy of measurements of specific analytes (ASO, CRP, RF) in patient samples, but it does not directly treat or diagnose a disease.
No
This device is a calibrator, used to ensure the accuracy of diagnostic tests for ASO, CRP, and RF. It does not directly diagnose conditions.
No
The device description explicitly states it is a "frozen liquid human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries" on clinical chemistry analyzers. Calibration materials used in conjunction with diagnostic tests to ensure accurate results are considered IVDs.
- Device Description: It's described as a "frozen liquid human serum matrix" used for calibration with clinical chemistry analyzers. This aligns with the nature of materials used in in vitro diagnostic procedures.
- Performance Studies: The summary of performance studies discusses its use in calibration and its equivalence to a predicate device (Beckman CAL 5 Plus), which is also likely an IVD calibrator.
The device is a calibrator, which is a type of reagent used in IVD testing to ensure the accuracy of the diagnostic results. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the calibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.
Product codes
JIX
Device Description
This SYNCHRON Systems CAL 5 Plus is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems CAL 5 Plus is for use in the calibration of SYNCHRON Systems Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries.
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
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 of the SYNCHRON Systems CAL 5 Plus to the Beckman CAL 5 Plus and is stable for ASO, CRP, and RF. The value assignment process for each analyte is correlated to a known standard via the anchor method. The SYNCHRON Systems CAL 5 Plus value assignment and verification processes yield acceptable calibrator assigned values for calibration on the SYNCHRON LX System and SYNCHRON CX Systems.
Key Metrics
Not Found
Predicate Device(s)
K926236/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.
0
Summary of Safety & Effectiveness SYNCHRON ® Systems CAL 5 Plus
JUN - 3 1997
1.0 Submitted By:
Sheri Hall Product Submissions Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8961 FAX: (714) 961-4457
Date Submitted: 2.0
28 March 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems CAL 5 Plus
3.2 Classification Name
(21 CFR § 862.1150) Calibrator
4.0 Predicate Device(s):
| SYNCHRON Systems
CAL 5 Plus | Predicate | Predicate Company | Docket
Number |
|--------------------------------|--------------------|------------------------------|------------------|
| SYNCHRON Systems
CAL 5 Plus | Beckman CAL 5 Plus | Beckman
Instruments, Inc. | K926236/A |
1
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems CAL 5 Plus Summary of Safety & Effectiveness
5.0 Description:
This SYNCHRON Systems CAL 5 Plus is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems CAL 5 Plus is for use in the calibration of SYNCHRON Systems Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries.
6.0 Intended Use:
The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the callibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreploysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.
7.0 Comparison to Predicate(s):
The SYNCHRON Systems CAL 5 Plus is a frozen liquid human serum matrix identical to the Beckman CAL 5 Plus product. The only difference between the Beckman CAL 5 Plus and the SYNCHRON Systems CAL 5 Plus is the instrument platform on which they are used. The Beckman Immunochemistry Systems are fully automated, specific protein analyzers, that measure by nephelometry; while the SYNCHRON Systems are fully automated, clinical chemistry analyzers that measure by spectrophotometry.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the SYNCHRON Systems CAL 5 Plus to the Beckman CAL 5 Plus and is stable for ASO, CRP, and RF. The value assignment process for each analyte is correlated to a known standard via the anchor method. The SYNCHRON Systems CAL 5 Plus value assignment and verification processes yield acceptable calibrator assigned values for calibration on the SYNCHRON LX System and SYNCHRON CX Systems.
| Stress
Temperature | Duration of
Incubation | Predicted
Stability | Beckman
Stability Claim* |
|-----------------------|---------------------------|------------------------|-----------------------------|
| 32°C | 40 Days | 32 Months | 24 Months |
| 37°C | 24 Days | 33 Months | 24 Months |
| 41°C | 15.5 Days | 32 Months | 24 Months |
| SYNCHRON Systems CAL 5 Plus Stability Testing Summary | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------- | -- | -- | -- | -- | -- |
- Expiration dating placed on the package based on date of manufacture
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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
Ms. Sheri Hall Product Submissions Manager ..... Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000
Re: K971283 Trade Name: SYNCHRON® Systems CAL 5 Plus Regulatory Class: II Product Code: JIX Dated: April 1, 1997 Received: April 7, 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 Regulations. 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 53 i through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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.
3
Page 2
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 $09.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) ﺍ 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
510(k) Number (if known):
SYNCHRON® Systems Device Name: CAL 5 Plus
Indications for Use:
The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the calibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.
21 CFR § 862.1150 Calibrator
(a) Identification. A 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.
(b) Classification. Class II.
Retire E. Rogers
(Division Sign-Off)
Division of Clinical La 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96