(37 days)
Abbott Lyophilized Assayed Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "Abbott Lyophilized Assayed Chemistry Control" device. This document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than presenting detailed study results or acceptance criteria for device performance.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not available in the provided text. The document does not describe a study that "proves the device meets the acceptance criteria" in terms of clinical or technical performance metrics.
However, I can extract what is implicitly stated about the device's intended use and regulatory status.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria or reported device performance data. The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. The general "acceptance criteria" here implicitly refer to meeting the regulatory requirements for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (Implicit/Stated in document) |
|---|---|
| Intended Use | For use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet. |
| Safety and Effectiveness | Determined to be "substantially equivalent" to legally marketed predicate devices, implying it meets established safety and effectiveness profiles for similar devices. |
| Compliance | Expected to comply with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Compliance with Current Good Manufacturing Practice requirements (21 CFR Part 820) is assumed. |
| CLIA Complexity Categorization | May require a CLIA complexity categorization (to be determined by contacting CDC). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document does not describe any specific test set or clinical study data.
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 available. The document does not describe the establishment of ground truth by experts for a test set. The substantial equivalence determination is made by the FDA based on the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available. There is no described test set or adjudication method.
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:
- Not applicable. This device is a chemistry control, not an imaging or diagnostic device typically evaluated with MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemistry control. It is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not available/Applicable in traditional sense. For a chemistry control, "ground truth" generally refers to the certified or assigned values for the analytes within the control material, established through rigorous analytical methods and calibration traceable to recognized standards. The document does not detail how these values were established, only that the device has "analytes listed in the value sheet."
8. The sample size for the training set:
- Not applicable. This device is a chemistry control, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a chemistry control, not a machine learning model.
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Public Health Service
MAR 1 8 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
K990394 Re:
Trade Name: Abbott Lyophilized Assayed Chemistry Control Regulatory Class: I Product Code: JJY Dated: February 8, 1999 Received: February 9, 1999
Dear Ms. Platt:
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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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 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/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
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510(k) Number: Device Name: Abbott Lyophilized Assayed Chemistry Control
Indications for Use:
Abbott Lyophilized Assayed Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | $990394 |
| Prescription Use | OR Over-The Counter Use |
|---|---|
| ------------------ | ------------------------- |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.