(55 days)
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No
The document describes a calibrator for a laboratory test system and does not mention any AI or ML components.
No
This device is a calibrator for a test system, not a device used to provide therapy or treatment to a patient.
No
This device is a calibrator, used to calibrate test systems for prealbumin. It is not directly used to diagnose a patient but rather to ensure the accuracy of diagnostic tests.
No
The device description clearly states it is a "human serum-based liquid calibrator set," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of prealbumin test systems" used on SYNCHRON CX Systems. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: It's a "human serum-based liquid calibrator set." Calibrators are used to establish a known relationship between the signal measured by an in vitro diagnostic instrument and the concentration of an analyte in a sample.
- Context: The device is used "in conjunction with SYNCHRON® Systems Prealbumin reagent," which is itself an in vitro diagnostic reagent used to measure prealbumin in biological samples.
- Predicate Device: The predicate device listed (K854811; Beckman Immunochemistry Systems CAL 3) is also a calibrator for an immunochemistry system, further indicating the IVD nature of this type of product.
Therefore, based on its intended use, description, and context within a diagnostic testing system, this device clearly falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SYNCHRON® CX Systems Prealbumin Calibrator is intended for use with the SYNCHRON CX Systems for the calibration of Prealbumin (PAB) reagent.
The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON CX Systems for the calibration of prealbumin test systems.
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.
Product codes (comma separated list FDA assigned to the subject device)
JIS
Device Description
The SYNCHRON CX Systems Prealbumin Calibrator Set is a six level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of a specific level of calibrator (identified as Levels 1 to Level 6).
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)
Stress stability studies of the Prealbumin 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.
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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized oval shape on the left, with two curved lines running through it. To the right of the oval shape is the text "BECKMAN" in a bold, sans-serif font, stacked above the text "COULTER", which is also in a bold, sans-serif font.
Summary of Safety & Effectiveness SYNCHRON® CX Systems Prealbumin Calibrator
1.0 Submitted By:
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
2.0 Date Submitted:
December 6, 1999
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® CX Systems Prealbumin Calibrator
3.2 Classification Name
Calibrator, (21 CFR §862.1150)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|-------------------------------------|---------------------------------------------|-----------------------|------------------|
| SYNCHRON® Systems
PAB Calibrator | Beckman
Immunochemistry
Systems CAL 3 | Beckman Coulter, Inc. | K854811 |
5.0 Description:
The SYNCHRON CX Systems Prealbumin Calibrator Set is a six level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of a specific level of calibrator (identified as Levels 1 to Level 6).
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
1
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® CX Systems Prealbumin Calibrator Summary of Safety & Effectiveness
5.0 Intended Use:
The SYNCHRON® CX Systems Prealbumin Calibrator is intended for use with the SYNCHRON CX Systems for the calibration of Prealbumin (PAB) reagent.
7.0 Comparison to Predicate(s):
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON | ||
| Systems CX PAB | ||
| Calibrator | Source Material: Fresh frozen human | |
| plasma that has been defibrinated and | ||
| processed. | Same as Beckman | |
| CAL 3 | ||
| 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 | ||
| Systems | ||
| PAB | ||
| Calibrator | Intended Use: | SYNCHRON CX Systems PAB Calibrator is |
| intended for use in calibration of SYNCHRON | ||
| CX Systems Prealbumin Reagent. | ||
| Beckman CAL 3 is intended for use in | ||
| calibration of albumin and prealbumin on | ||
| ARRAY®, ARRAY® 360, and IMMAGE™ | ||
| Immunochemistry systems | ||
| Levels of Analyte | SYNCHRON Systems PAB Calibrator: 6 | |
| levels | ||
| Beckman CAL 3: 1 level |
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 Prealbumin 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.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
3 2000 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104 Box 8000 Brea, California 92822-8000
Re: K994169
Trade Name: SYNCHRON® CX Systems Prealbumin Calibrator Regulatory Class: II Product Code: JIS Dated: December 6, 1999 Received: December 10, 1999
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 Quality 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.
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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" (21CFR 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 Butman
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
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page ⊥ of ⊥
510(k) Number (if known): Y 44 4 / 69
510(k) Number (If Known): n777169
Device Name: SYNCHRON® CX Systems
Prealbumin Calibrator
Indications for Use:
The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON CX Systems for the calibration of prealbumin test systems.
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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical tory Devices 510(k) Number
(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)
OR
Over-the-Counter Use Optional Format 1-2-96