(61 days)
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.
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.
The provided document is a 510(k) summary for the Beckman Calibrator 2 (CAL2), a device used for calibrating diagnostic instruments. It describes the device's intended use and compares it to predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or performance data typically associated with studies proving a device meets specific acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or human reader performance with AI assistance.
The document states: "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 indicates that internal testing was conducted to ensure the calibrator's values were acceptable and correlated to known standards, consistent with establishing substantial equivalence to existing predicate devices. However, it does not provide the specific numerical acceptance criteria or the raw performance data from such a study.
Therefore, much of the requested information cannot be extracted from this specific document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document implies "acceptable calibrator assigned values" and "correlation to a known standard" as criteria for "substantial equivalence." | - "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."- The device was found substantially equivalent to predicate devices (K771603, K780913, K791339, K791340, K901977, K940353). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). The document only mentions "The data in the Premarket Notification."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable/Not specified. This device is a calibrator for in-vitro diagnostic tests, not an interpretive AI device for medical images or clinical decision support that would typically involve expert ground truth establishment for a test set in the same way. The ground truth for a calibrator would be an established reference standard or a method traceable to an international standard.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on image interpretation or clinical diagnosis, which is not the primary function of a calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure performance improvement. The Beckman Calibrator 2 is a diagnostic calibrator, not an AI-powered diagnostic tool used by human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in spirit. The testing described (though lacking detail) focuses on the performance of the calibrator itself in assigning values and its compatibility with the instruments. This is analogous to a "standalone" performance evaluation of the calibrator's function, independent of human operators, beyond its intended use in calibrating the instrument. The "value assignment and verification processes" would be an assessment of the calibrator's intrinsic performance.
7. The Type of Ground Truth Used
- Known Standard / Anchor Method: The document states, "The value assignment process for each analyte is correlated to a known standard via the anchor method." This implies that the ground truth for the calibrator's values is established by comparing them to pre-defined, validated reference materials or methods.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This is a calibrator, not an AI algorithm that undergoes "training" in the machine learning sense. Its values are assigned using a chemical process and verified against standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified, as this device does not have a "training set" in the context of AI. The "ground truth" for the calibrator's values is established through correlation to "known standards via the anchor method."
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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 |
|---|---|---|---|
| BeckmanCalibrator 2 | BeckmanCalibrator 2 | BeckmanInstruments, 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.
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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
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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.
§ 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.