(25 days)
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No
The document describes a validator set for enzyme assays on clinical chemistry analyzers, focusing on chemical reagents and calibration, with no mention of AI or ML technologies.
No
This device is an "Enzyme Validator Set" used to provide reference points for measuring human enzymes on specific laboratory systems. It is not used for treating or diagnosing a disease or condition in a patient.
No
Explanation: The device is described as an "Enzyme Validator Set" used to provide "points of reference in the measurement of selected human enzymes" and to validate assay values. This indicates it is a calibration or quality control product used to ensure the accuracy of other diagnostic tests, rather than a diagnostic device itself.
No
The device description explicitly states that the kit consists of physical components: 3 X 5 mL of Levels 1 and 2 of SYNCHRON Enzyme Validator, two calibration diskettes, an instruction insert, and an Assigned Values sheet. These are not software components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to provide points of reference in the measurement of selected human enzymes." This indicates that it is used to analyze human samples (in vitro) to obtain information about a person's health status (diagnostic).
- Device Description: The device is designed for use on "Beckman SYNCHRON® Systems," which are laboratory analyzers used for clinical chemistry testing.
- Performance Data: The mention of "Performance data from validation testing supports equivalency" implies that the device is subject to performance evaluation for its intended diagnostic purpose.
- Predicate Device: The predicate device listed (K984014; SYNCHRON® Systems Validator Set) is also an IVD, which further supports the classification of this device as an IVD.
The device is a "validator set," which is a type of control material used in IVD testing to ensure the accuracy and reliability of the assay results. While it doesn't directly diagnose a condition, it is an essential component of the IVD testing process.
N/A
Intended Use / Indications for Use
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON® Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values are specific for the LIP chemistry on SYNCHRON Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The SYNCHRON Systems Enzyme Validator Set is designed for optimal performance on the SYNCHRON CX (CX4/CX4CE/CX4A/CX4PRO, CX5/CX5CE/CX5A/CX5PRO. CX7/CX7RTS/CX7Δ/CX7PRO, CX9ALX /CX9PRO) and LX (LX20/LXPRO/LXi) Systems. Each kit of SYNCHRON Enzyme Validator consists of 3 X 5 mL each of Levels 1 and 2 of SYNCHRON Enzyme Validator, two (2) calibration diskettes, one (1) instruction insert, and one (1) Assigned Values sheet.
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)
Performance data from validation testing supports equivalency.
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).
This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications -Issue Date: March 20, 1998
§ 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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AUG 1 8 2003
510(k) SUMMARY
1.0 Submitted By:
Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
2.0 Date Submitted
July 23, 2003
3.0 Device Name(s):
- 3.1 Proprietary Names SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2
- 3.2 Classification Names Calibrator. [862.1150]
4.0 Legally Marketed Device
The SYNCHRON® Systems Enzyme Validator Set claims substantial equivalence to the SYNCHRON® Systems Validator Set currently in commercial distribution. (FDA 510(k) Number K984014)
5.0 Device Description
The SYNCHRON Systems Enzyme Validator Set is designed for optimal performance on the SYNCHRON CX (CX4/CX4CE/CX4A/CX4PRO, CX5/CX5CE/CX5A/CX5PRO. CX7/CX7RTS/CX7Δ/CX7PRO, CX9ALX /CX9PRO) and LX (LX20/LXPRO/LXi) Systems. Each kit of SYNCHRON Enzyme Validator consists of 3 X 5 mL each of Levels 1 and 2 of SYNCHRON Enzyme Validator, two (2) calibration diskettes, one (1) instruction insert, and one (1) Assigned Values sheet.
1
Intended Use 6.0
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON® Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values are specific for the LIP chemistry on SYNCHRON Systems.
7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)
The SYNCHRON Enzyme Validator Set has been value assigned for ALT, AMY, AST, CK, GGT and LD using the new 2002 IFCC reference method. Additionally, Amylase (AMY) has been added to the list of analytes traceable to the IFCC reference method. There has been no change to the calibrator's formula. AMY was present in the predicate calibrator but was never value assigned.
8.0 Summary of Performance Data
Performance data from validation testing supports equivalency.
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Section 1: ADMINISTRATIVE INFORMATION
1.0 Submitted By:
Beckman Coulter. Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000
Primary Contact: Kim Walker, Senior Regulatory Affairs Specialist Telephone: (714) 961-4912 FAX: (714) 961-4123 E-mail: kawalker@beckman.com
Secondary Contact: Annette Hellie, Staff Regulatory Specialist Telephone: (714) 993-8767 FAX: (714) 961-4123 E-mail: athellie@beckman.com
2.0 Sponsor Address/FDA Registration Number
Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Establishment Registration No. 2050012
3.0 Product Name/Classification Name and Number
Proprietary Names
SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2
Classification Names
Calibrator [862.1150]
4.0 Device Classification
FDA has classified clinical chemistry test systems of this type into Class II.
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5.0 Section 514 Compliance
This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications -Issue Date: March 20, 1998
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows a black and white drawing of a logo or symbol. The symbol consists of a circle made of small dots, with three curved lines extending from the right side of the circle. The lines are thick and black, and they appear to be stylized representations of something like waves or motion. The overall design is simple and abstract.
AUG 1 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd, M/S - W-104 Box 8000 Brea, CA 92822-8000
K032287 Re:
Trade/Device Name: SYNCHRON® Systems Enzyme Validator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 23, 2003 Received: July 24, 2003
Dear Ms. Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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page 1 of 1
510(k) Number (if known): K 032287
SYNCHRON® Systems Enzyme Validator Set Device Name:
Indications for Use:
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON® Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values are specific for the LIP chemistry on SYNCHRON Systems.
(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
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032287