(71 days)
Not Found
Not Found
No
The summary describes a calibrator for a clinical chemistry system, which is a standard laboratory reagent, and there is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is an in vitro diagnostic calibrator used to establish reference points for determining protein values, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device."
No
The device description clearly states it is a "liquid human serum-based product supplied as a kit of ten vials," indicating it is a physical, in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Special Protein Calibrator for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to establish points of reference that are used in determination of human IgA, IgG, IgM, complement C3, complement C4, and Transferrin values."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Special Protein Calibrator is intended to be used to calibrate the complement component, C3 (C3), complement component,C4 (C4), Transferrin (TRNF), Immunoglobulin G (IGG), Immunoglobulin A (IGA), and Immunoglobulin M (IGM) methods on the Dimension® clinical chemistry system.
The Special Protein Calibrator for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to establish points of reference that are used in determination of human IgA, IgG, IgM, complement C3, complement C4, and Transferrin values.
Product codes
JIT
Device Description
The Dimension® Special Protein Calibrator is a liquid human serum-based product supplied as a kit of ten vials; two at each of five levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Beckman CAL 1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAR - 1 2000
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 21CFR$807.92.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | December 20, 1999 |
| Name of Product: | Dimension® Special Protein Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Beckman CAL 1 |
| Device Description: | The Dimension® Special Protein Calibrator is a liquid human serum-
based product supplied as a kit of ten vials; two at each of five levels. |
| Intended Use: | The Special Protein Calibrator is intended to be used to calibrate the
complement component, C3 (C3), complement component,C4 (C4),
Transferrin (TRNF), Immunoglobulin G (IGG), Immunoglobulin A
(IGA), and Immunoglobulin M (IGM) methods on the Dimension®
clinical chemistry system. |
Comparison to Predicate Device:
| Dimension® | ||
|---|---|---|
| Device | Beckman CAL 1 | Special Protein Calibrator |
| Intended Use: | Calibrator | Calibrator |
| Analytes: | Complement C3 (C3) | |
| Complement C4 (C4) | ||
| Transferrin (TRF) | ||
| Immunoglobulin G (IgG) | ||
| Immunoglobulin A (IgA) | ||
| Immunoglobulin M (IgM) | ||
| Alpha₁ -acid glycoprotein (AAG) | ||
| Haptoglobin (HPT) | ||
| Kappa light chain (KAP) | ||
| Lambda light chain (CAM) | Complement C3 (C3) | |
| Complement C4 (C4) | ||
| Transferrin (TRNF) | ||
| Immunoglobulin G (IGG) | ||
| Immunoglobulin A (IGA) | ||
| Immunoglobulin M (IGM) | ||
| Matrix: | ||
| Form: | ||
| Volume: | ||
| Levels: | ||
| Reference: | Human serum base | |
| Liquid | ||
| 3.0 mL per vial, reconstituted | ||
| 1 level | ||
| IFCC, CRM 470 | Human serum base | |
| Liquid | ||
| 1.5 mL per vial | ||
| 5 levels | ||
| IFCC, CRM 470 |
1
Comments on Substantial Equivalence:
Both the Beckman CAL 1 and the Dimension® Special Protein Calibrator are intended as calibrators for C3, C4, Transferrin, IgG, IgA, and IgM methods.
Conclusion:
The Dimension® Special Protein Calibrator is substantially equivalent to the Beckman CAL 1 calibrator based on the comparison discussed above.
K.M. Knight
Richard M. Vaught Regulatory Affairs and Compliance Manager Date: December 20, 1999
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
MAR = 1 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714-6101
Re: K994291 Trade Name: Dimension® Special Protein Calibrator Regulatory Class: II Product Code: JIT Dated: December 20, 1999 Received: December 21, 1999
Dear Mr. Vaught:
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.
3
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 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
INDICATIONS FOR USE STATEMENT
Device Name:
Dimension® Special Protein Calibrator
Indications for Use:
The Special Protein Calibrator for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to establish points of reference that are used in determination of human IgA, IgG, IgM, complement C3, complement C4, and Transferrin values.
Richard M. Vaught Regulatory Affairs and Compliance Manager
在新闻网易是民营商品名誉的地址:老宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝
February 17, 2000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Mahison
(Division Sign-Division of Clinical Laboratory Dev 510(k) Numbe
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use_
(Optional format 1-2-96)