(35 days)
LiniCAL™ Protein 3 Calibration Verifiers Levels A – E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage™
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The provided document is a 510(k) clearance letter from the FDA for a quality control material, not a device that relies on an algorithm or AI. Therefore, it does not contain the specific information requested about acceptance criteria, study details, expert involvement, or AI performance metrics.
However, based on the context of the document, I can infer some aspects related to "acceptance criteria" in a general sense for this type of product and the "study" that supports its clearance.
Inferred Acceptance Criteria and "Study" for LiniCAL™ Protein 3 Calibration Verifiers:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a quality control material used to verify calibration and assess linearity, the "acceptance criteria" and "reported device performance" would likely revolve around the material's ability to consistently provide expected values when tested on the target instrument (Beckman-Coulter Immage™).
| Acceptance Criteria Category | Reported Device Performance (Inferred) |
|---|---|
| Value Consistency (Intra-Lot) | Each level (A-E) demonstrates consistent analyte concentrations within established analytical limits across different vials from the same manufacturing lot. |
| Value Consistency (Inter-Lot) | Each level (A-E) demonstrates consistent analyte concentrations across different manufacturing lots, within established analytical limits. |
| Stability | The material maintains its analyte concentrations within specified limits over its claimed shelf-life and under recommended storage conditions. |
| Matrix Effects | The material's matrix does not interfere with the reliable measurement of Protein 3 on the Beckman-Coulter Immage™ system. |
| Assigned Values Accuracy | The assigned values for each level (A-E) are accurately determined and traceable to a reference method or material. |
| Linearity Verification Efficacy | When used as intended, the material helps verify the linearity of the Beckman-Coulter Immage™ system for Protein 3, allowing for detection of non-linear responses. |
| Predicate Device Equivalence | Performance characteristics (e.g., value ranges, stability) are substantially equivalent to a legally marketed predicate quality control material for Protein 3. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. For a quality control material, this would typically involve testing multiple replicates of each level across several manufacturing lots and potentially different instruments.
- Data Provenance: Not specified, but likely from internal testing conducted by CLINIQUA Corporation. Given the nature of a 510(k), it would be retrospective data collected during product development and validation. The country of origin would likely be the USA, where CLINIQUA Corporation is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For a quality control material, "ground truth" establishment would involve laboratory scientists or chemists with expertise in assay development, validation, and quality control. They would be responsible for assigning reference values to the material.
- The exact number and qualifications are not stated, but it would involve personnel trained in clinical chemistry and analytical method validation, likely with several years of experience in an IVD manufacturing environment. There wouldn't be "experts" in the same way as, say, radiologists reviewing images, but rather the internal scientific team.
4. Adjudication Method for the Test Set:
- Not applicable in the sense of expert review for diagnostic decisions. The "adjudication" would be a data review process by an internal quality assurance or R&D team against predefined acceptance criteria for analytical performance. This would be based on statistical analysis of the test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study is not applicable to a calibration verifier/quality control material. MRMC studies are used for diagnostic devices that involve human interpretation (e.g., imaging devices).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemical reagent, not an algorithm. Its "performance" is its chemical and physical stability and its ability to provide accurate and consistent assay values.
7. The Type of Ground Truth Used:
- The ground truth would be assigned values derived from reference methods or certified reference materials (if available) for Protein 3, established through rigorous analytical testing and metrological traceability. This is akin to "verified analytical values."
8. The Sample Size for the Training Set:
- Not applicable. This device is not an algorithm that requires a "training set." It is a manufactured material.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no training set for a quality control material.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a human profile incorporated into the design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 02 2002
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQUA Corporation 1432 South Mission Road Fallbrook, CA 92028
Re: K022867
Trade/Device Name: LiniCAL™ Protein 3 Calibration Verifiers Levels A-E for Beckman Coulter Immage™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unasayed) Regulatory Class: Class I Product Code: JJY Dated: August 21, 2002 Received: August 28, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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/cdrl/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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 (if known): K022867
Device Name: LiniCAL ™ Protein 3 Calibration Verifiers Levels A - E for the Beckman-Coulter Immage™
Indications For Use:
LiniCAL™ Protein 3 Calibration Verifiers Levels A – E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage™
tean Cooper
(Division Sign-Off)
Division of Clinical Labora
510(k) Number K022862
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.