(44 days)
Prealbumin Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prealbumin (PALB) method on the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Prealbumin (PALB) Calibrator for the Dimension® clinical chemistry system is a liquid product. The Level 1 calibrator is bovine albumin based with no detectable prealbumin. Levels 2 through 5 contain human prealbumin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.
The provided text is related to a 510(k) submission for a medical device: "Prealbumin (PALB) Calibrator." This summary focuses on the substantial equivalence of the calibrator to a predicate device and its intended use. It does not describe a study with acceptance criteria and device performance in the context of an AI/ML or diagnostic imaging device.
Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and study results in the specified format, as the provided text doesn't contain that kind of performance data. The document confirms regulatory clearance based on substantial equivalence, which is a different type of evaluation.
Here's why the specific questions cannot be answered from the provided text:
- Acceptance Criteria and Reported Device Performance: This document establishes the device as a calibrator and compares it to a predicate device based on characteristics like "intended use," "analyte," "matrix," "form," "volume," and "levels." It does not provide any performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) against specific acceptance criteria.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these points relate to performance studies, especially those for AI/ML or diagnostic devices where performance is measured against a ground truth. Since this is a calibrator and the submission focuses on substantial equivalence, no such performance studies or associated details are included.
The closest information provided is:
- Device Name: Prealbumin (PALB) Calibrator
- Intended Use: To calibrate the Prealbumin method on the Dimension® clinical chemistry system.
- Comparison to Predicate Device: The table provided lists comparative features between the Dimension® Prealbumin Calibrator and the SPQ™ Prealbumin Calibrator. This is the basis for the "substantial equivalence" claim, not a performance study.
{0}------------------------------------------------
Dade Behring
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Rebecca S. AyashDade Behring Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | 6/30/98 |
| Device Name: | Prealbumin (PALB) Calibrator |
| Classification Name: | Calibrator, Secondary |
| Predicate Device: | Calibration Set for Prealbumin SPQTM Test System |
Device Description: Prealbumin (PALB) Calibrator for the Dimension® clinical chemistry system is a liquid product. The Level 1 calibrator is bovine albumin based with no detectable prealbumin. Levels 2 through 5 contain human prealbumin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.
Intended Use: Prealbumin Calibrator is intended to be used to calibrate the Prealbumin method on the Dimension® clinical chemistry system.
Comparison to Predicate Device:
| Dimension® PrealbuminCalibrator | SPQ™ Prealbumin Calibrator | |
|---|---|---|
| Intended Use | calibrator | calibrator |
| Analyte | human prealbumin | human prealbumin |
| Matrix | bovine albumin | human serum |
| Form | liquid | liquid |
| Volume | 1.0 mL per vial | 1.0 mL per vial |
| Levels | 5 levels | 5 levels |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized depiction of an eagle, with its wings forming three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 3 1998
Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
K982292 Re : Prealbumin (PALB) Calibrator Requlatory Class: II Product Code: JIT Dated: June 30, 1998 Received: July 1, 1998
Dear Ms. Ayash:
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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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.
{2}------------------------------------------------
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 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/dsmamain.html".
Sincerely yours,
Steven Litman
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
{3}------------------------------------------------
Indications Statement
Device Name: Prealbumin (PALB) Calibrator
Indications for Use: Prealbumin Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prealbumin (PALB) method on the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Rebecca S. Ayesh
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 6/30/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
/ Prescription Device
K482242
510(k) Number
Division Sign Off
Division Sign-Off Office of Device Evaluation
§ 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.