(21 days)
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No
The document describes a calibrator for a laboratory system and does not mention any AI or ML components or functions.
No
This device is a calibrator, used for the calibration of Microalbumin tests for diagnostic purposes, not for direct therapeutic treatment.
No
The device is a calibrator, used for the calibration of microalbumin measurements on the SYNCHRON CX Systems. It helps ensure the accuracy of diagnostic tests but is not a diagnostic device itself.
No
The device description explicitly states it is a "product" containing "bottles" of "Microalbumin Calibrator," indicating a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of Microalbumin" when used with a specific reagent on a SYNCHRON CX System. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: It's described as a "Microalbumin Calibrator" intended for use on a SYNCHRON CX System with a specific reagent. Calibrators are essential components of many IVD systems.
- Predicate Device: The predicate device listed (K973928; Beckman Immunochemistry Systems Urine Protein Calibrator (UCAL)) is also a calibrator used in an immunochemistry system, which are typically IVD systems.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the function and context of a calibrator used with a reagent on a clinical analyzer strongly indicate its role in an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The SYNCHRON CX Systems Microalbumin Calibrator is a six-level calibrator intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin (MA) reagent.
MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.
Product codes (comma separated list FDA assigned to the subject device)
JIS
Device Description
The SYNCHRON CX® Systems Microalbumin Calibrator , when used in conjunction with SYNCHRON Systems Microalbumin Systems Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin. This product contains a 3.0 mL bottle each of Levels 1 to 6 of Microalbumin Calibrator.
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stress stability studies of the Microalbumin calibrator support the Beckman stability claim of 24 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol to the left of the company name. The symbol appears to be an abstract representation of a cell or a fluid dynamic, rendered in a textured, dark color. To the right of the symbol, the words "BECKMAN" and "COULTER" are stacked vertically, with each word in bold, sans-serif font.
Summary of Safety and Effectiveness SYNCHRON CX® Systems Microalbumin Calibrator
1.0 Submitted By:
Gail Lefebre Associate Requlatory 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:
December 17, 1999
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON CX® Systems Microalbumin Calibrator
3.2 Classification Name
Calibrator, Primary (21 CFR § 862.1150)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|----------------------------------------------------|--------------------------------------------------------------------------|-----------------------|------------------|
| SYNCHRON CX®
Systems Microalbumin
Calibrator | Beckman
Immunochemistry
Systems Urine Protein
Calibrator (UCAL) | Beckman Coulter, Inc. | K973928 |
5.0 Description:
The SYNCHRON CX® Systems Microalbumin Calibrator , when used in conjunction with SYNCHRON Systems Microalbumin Systems Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin. This product contains a 3.0 mL bottle each of Levels 1 to 6 of Microalbumin Calibrator.
6.0 Intended Use:
The SYNCHRON CX Systems Microalbumin Calibrator is a six-level calibrator intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin (MA) reagent.
Beckman Coulter, Inc. 200 S. Kraemer Boulevard Brea, CA 92821
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
994325
1
7.0 Comparison to Predicate(s):
| Beckman Product | Predicate | Predicate Company | Docket Number |
|---|---|---|---|
| SYNCHRON CX® | |||
| Systems Microalbumin | |||
| Calibrator | Beckman | ||
| Immunochemistry Systems | |||
| Urine Protein Calibrator | |||
| (UCAL) | Beckman Coulter, Inc. | K973928 |
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON Systems CX MA | ||
| Calibrator | Intended for calibration of urine | |
| Microalbumin reagents | Same as UCAL | |
| Storage Temperature (+2°C to +8°C) | ||
| Liquid, ready-to-use form | ||
| Value Assignment Methodology | ||
| Traceable to the IFCC reference | ||
| preparation for plasma proteins, lot CRM |
- | |
| Reagent | Aspect/
Characteristic | Comments |
|--------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYNCHRON CX Systems
MA Calibrator | Intended Use: | SYNCHRON CX Systems MA Calibrator is
intended for use in calibration of SYNCHRON CX
Systems Microalbumin Reagent. |
| | | Beckman Immunochemistry Systems UCAL is
intended for use in calibration of microalbumin,
urine transferrin, alpha-1-microglobulin, and urine
immunoglobulin G on ARRAY®, ARRAY® 360,
and IMMAGE™ Immunochemistry Systems. |
| | Levels of
Analyte: | SYNCHRON Systems MA Calibrator: 6 levels |
| | | Beckman UCAL: 4 levels |
| | Source
Material: | CX MA pH buffer to which human serum albumin
has been added |
| | | UCAL is prepared from human urine to which
albumin has been added |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stress stability studies of the Microalbumin calibrator support the Beckman stability claim of 24 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 regulation 21 CFR 807.92.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircling it. The text is written in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 2 2000
Ms. Gail Lefebvre Associate Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., M/S W-104 Brea, California 92822-8000
Re: K994325
Trade Name: SYNCHRON CX® Systems Microalbumin Calibrator Regulatory Class: II Product Code: JIS Dated: December 17, 1999 Received: December 22, 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 (OS) 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 (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
4
Page _ of _
510(k) Number (if known): $994325
Device Name: SYNCHRON CX® Systems Microalbumin Calibrator
Indications for Use:
MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.
Clinical Significance:
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.
Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994325
(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)
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96