(13 days)
LiniCAL® Protein 5 Calibration Verifiers Levels A - E for Beckman Coulter Array and Immage® Protein Systems is intended for use as an assayed quality control material for analysis.
Not Found
Following is a breakdown of the requested information based on the provided text. It's important to note that the document is an FDA 510(k) clearance letter, which means it evaluates substantial equivalence to a predicate device rather than providing detailed study results for novel acceptance criteria. Therefore, much of the requested information (especially regarding specific performance metrics, sample sizes for training/test sets, expert adjudication, MRMC studies, and standalone performance) is NOT typically found in such a letter.
Device Name: LiniCAL™ Protein 5 Calibration Verifiers Levels A - E for Beckman Coulter Array® and Immage® Protein Systems
1. A table of acceptance criteria and the reported device performance
The provided FDA 510(k) clearance letter does not specify "acceptance criteria" for the LiniCAL™ Protein 5 Calibration Verifiers, nor does it report specific performance metrics from a study against such criteria. The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device's performance is considered comparable to the predicate for its intended use, but the specific numerical targets or results are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the FDA 510(k) clearance letter.
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)
This information is not provided in the FDA 510(k) clearance letter. For a calibration verifier, "ground truth" would typically refer to the established true values of the analytes within the verifier materials, often determined through highly precise reference methods, not expert consensus in the human interpretation sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the FDA 510(k) clearance letter. Adjudication methods are not applicable to the assessment of a calibration verifier.
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
An MRMC study is not applicable and was not done for this type of device. The device is a "Calibration Verifier" for laboratory instruments, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation in the context of an algorithm is not applicable for this device. This device is a physical calibration material used in conjunction with existing laboratory instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibration verifier, the "ground truth" would typically be the assigned target values (or certified values) for the analytes within the verifier materials, established through rigorous analytical methods (e.g., gravimetric preparation, reference methods, or consensus values from inter-laboratory studies). The document does not specify how these values were established for this particular device or its predicate.
8. The sample size for the training set
This information is not provided in the FDA 510(k) clearance letter. Calibration verifiers do not typically involve "training sets" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not provided in the FDA 510(k) clearance letter, as "training sets" are not applicable to this type of device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 28 2003
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432 South Mission Road Fallbrook, California 92028
Re: K030150
Trade/Device Name: LiniCAL™ Protein 5 Calibration Verifiers Levels A - E for Beckman Coulter Array® and Immage® Protein Systems Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Controls Material, (Assayed and Unassayed) Regulatory Class: I Product Code: JJY Dated: January 14, 2003 Received: January 15, 2003
Dear Ms. Ruggiero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
030/50
Device Name: LiniCAL® Protein 5 Calibration Verifiers Levels A – E for Beckman Coulter Array® and Immage® Protein Systems
Indications For Use:
LiniCAL® Protein 5 Calibration Verifiers Levels A - E for Beckman Coulter Array and Immage® Protein Systems is intended for use as an assayed quality control material for analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
Division Sign Off
on of Clinical Laboratory Devices
510(k) Number K1030150
Prescription Use
(Per 21 CFR 801.109)
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.