(61 days)
No
The document describes a calibrator for laboratory tests and does not mention any AI or ML components.
No.
The device is a calibrator for in vitro diagnostic reagents and is not used for direct treatment or diagnosis of a disease or condition.
No
This device is described as a "Calibrator" used to adjust pre-programmed calibration curves for determining concentration values of various substances in test specimens. Its function is to ensure the accuracy of measurements rather than to diagnose a condition directly.
No
The device description clearly states it is derived from fresh frozen human plasma and is a physical calibrator used in conjunction with reagents and specific hardware systems (Array®, Array® 360, and IMMAGE™ Systems). It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is used "for the calibration of these reagents" which are used to determine concentration values of various substances in "test specimens." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details that it is used to "adjust pre-programmed calibration curves from which... concentration values are determined for test specimens." This further reinforces its role in the diagnostic process.
- Predicate Devices: The listed predicate devices are all named "Beckman Calibrator 2," which are known IVD calibrators. This indicates that the device falls within the same regulatory category as its predecessors.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the intended use and function of the device clearly place it within this category.
N/A
Intended Use / Indications for Use
CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha,-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alphamacroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
Product codes
JIX, JZG, CZP, DCF, DDB, DEB, JBQ
Device Description
Beckman Calibrator 2 is derived from fresh frozen human plasma that has been defibrinated and processed. Assay of CAL 2 provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which AAT, CER, PFB, B2M, AMG, and AT3 concentration values are determined for test specimens.
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
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. The value assignment process for each analyte is correlated to a known standard via the anchor method. The Beckman Calibrator 2 value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems.
Key Metrics
Not Found
Predicate Device(s)
K771603, K780913, K791339, K791340, K901977, K940353
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
BECKMAN
KCN3932
DFC 1 5 1997
Summary of Safety & Effectiveness Beckman Calibrator 2 (CAL2)
Submitted By: 1.0
Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
October 14, 1997
3.0 Device Name(s):
Proprietary Names 3.1
Beckman Calibrator 2 (CAL2)
Classification Name 3.2
Calibrator (21 CFR § 862.1150)
4.0 Predicate Device(s):
| Device | Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| Beckman | |||
| Calibrator 2 | Beckman | ||
| Calibrator 2 | Beckman | ||
| Instruments, Inc. | K771603 (AAT) | ||
| K780913 (PFB) | |||
| K791339 (CER) | |||
| K791340 (AMG) | |||
| K901977 (AT3) | |||
| K940353 (B2M) |
5.0 Description:
Beckman Calibrator 2 is derived from fresh frozen human plasma that has been defibrinated and processed. Assay of CAL 2 provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which AAT, CER, PFB, B2M, AMG, and AT3 concentration values are determined for test specimens.
1
6.0 intended Use:
CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha-antitypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alpha-macroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
7.0 Comparison to Predicate(s):
The Beckman Calibrator 2 is a lyophilized human serum matrix identical to the current product. The only difference is the additional instrument platform on which it will be used. The existing Beckman CAL 2 is used with Beckman's Array® and Array® 360 Immunochemistry Systems. These systems are fully automated, specific protein analyzers, that measure by nephelometry. The new instrument platform, the IMMAGE™ Immunochemistry System, is also a fully automated, specific protein analyzer that measures by nephelometry.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. The value assignment process for each analyte is correlated to a known standard via the anchor method. The Beckman Calibrator 2 value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a person with outstretched arms, with three lines forming the body and arms. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 5 1997
Annette Hellie Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 P.O. Box 8000 Brea, California 92822-8000
Re: K973932 Beckman Calibrator 2 Regulatory Class: II Product Code: JIX, JZG, CZP, DCF, DDB, DEB, JBQ Dated: October 14, 1997 Received: October 15, 1997
Dear Ms. Hellie:
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 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. ਜੋ 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 requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (sail 00), on. 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 premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Steven Sitman
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
page page of
510(k) Number (if known):
Beckman Calibrator 2 (CAL2) Device Name:
Indications for Use:
CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha,-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alphamacroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
21 CFR 862.1150 Calibrator
(a) Identification. A calibrator if 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.
(b) Classification. Class II
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/4/Figure/9 description: The image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form has two options: "Prescription Use (per 21 CFR 801.109)" and "Over-the-Counter Use Optional Format 1-2-96". The "Prescription Use" option is selected. There is also a signature and a number "R973932" at the bottom of the form.