(55 days)
The SYNCHRON® LX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON LX Systems for the calibration of prealbumin test systems.
The SYNCHRON Systems Prealbumin Calibrator is a ready-to-use human serum-based liquid calibrator manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of the calibrator.
The provided document is a 510(k) summary for the SYNCHRON® LX Systems Prealbumin Calibrator. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes very limited performance data. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability: The calibrator should remain stable for a specified duration. The predicate device, and by implication, the new device, is expected to meet stability requirements. | Stress Stability Studies: Support a Beckman stability claim of 24 months. |
Note: The document does not explicitly state acceptance criteria in a quantitative or statistical manner for performance metrics like accuracy, precision, or linearity. The primary "performance" discussed is related to stability and equivalence to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any performance testing other than the mention of "stress stability studies."
- Data Provenance: Not specified. It can be inferred that the studies were conducted by Beckman Coulter, Inc. (USA), but details about the origin of the samples within those studies are not provided.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a calibrator for laboratory assays, not an imaging or diagnostic device requiring expert interpretation of results to establish ground truth in the way a medical image or clinical diagnosis would. Ground truth for a calibrator would typically be established through highly accurate reference methods or certified reference materials traceable to international standards (e.g., IFCC reference preparation for plasma proteins, lot CRM 470, as mentioned for value assignment methodology).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the device is a calibrator, there is no "adjudication" in the sense of reconciling differing expert opinions on a diagnostic outcome. The value assignment methodology (traceable to IFCC reference preparation) serves as the "ground truth" establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This is a calibrator for an in-vitro diagnostic system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical calibrator, not an algorithm or software. Its performance is evaluated by its ability to accurately calibrate the SYNCHRON® LX Systems Prealbumin Reagent.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the calibrator's value assignment is based on traceability to the IFCC reference preparation for plasma proteins, lot CRM 470. This indicates that the calibrator’s concentration values are assigned using a well-established and internationally recognized reference standard.
8. The sample size for the training set
- Not applicable. This document describes a calibrator; there is no mention of a "training set" as it would apply to machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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3 2000 FEB
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved lines inside, resembling a stylized eye or leaf. To the right of the circle is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The two words are stacked vertically, with "BECKMAN" on top of "COULTER."
Summary of Safety & Effectiveness SYNCHRON® LX 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® LX Systems Prealbumin Calibrator
3.2 Classification Name
Calibrator, (21 CFR §862.1150)
4.0 Predicate Device(s):
| SYNCHRON SystemsReagent | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| SYNCHRON® SystemsPAB Calibrator | BeckmanImmunochemistrySystems CAL 3 | Beckman Coulter, Inc. | K854811 |
5.0 Description:
The SYNCHRON Systems Prealbumin Calibrator is a ready-to-use human serum-based liquid calibrator manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of the calibrator.
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® LX Systems Prealbumin Calibrator Summary of Safety & Effectiveness
5.0 Intended Use:
The SYNCHRON® LX Systems Prealbumin Calibrator is intended for use with the SYNCHRON LX Systems for the calibration of Prealbumin (PAB) reagent.
7.0 Comparison to Predicate(s):
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON LXSystems PABCalibrator | Source Material: Fresh frozen humanplasma that has been defibrinated andprocessed. | Same as BeckmanCAL 3 |
| Storage Temperature (+2°C to +8°C) | ||
| Liquid, ready-to-use form | ||
| One level of analyte | ||
| Value Assignment Methodology | ||
| Traceable to the IFCC referencepreparation for plasma proteins, lot CRM470. |
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRONLX SystemsPABCalibrator | Intended Use: | SYNCHRON LX Systems PAB Calibrator isintended for use in calibration of SYNCHRONLX Systems Prealbumin Reagent.Beckman CAL 3 is intended for use incalibration of albumin and prealbumin onARRAY®, ARRAY® 360, and IMMAGE™Immunochemistry systems |
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 Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized depiction of three human figures, representing the department's focus on people and their well-being. The figures are rendered in a simple, abstract style.
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: K994168
Trade Name: SYNCHRON® LX 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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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 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):
: 13774168
ON@LX Systems
Device Name: SYNCHRON® LX Systems Prealbumin Calibrator
Indications for Use:
The SYNCHRON® LX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON LX 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.
Dean Coogy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 9941(08
(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
§ 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.