(21 days)
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.
While the provided document is a 510(k) clearance letter for the Olympus AU5400 Clinical Chemistry Analyzer, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in the actual 510(k) submission or a scientific publication.
The letter confirms that the device has been found substantially equivalent to predicate devices, meaning it is considered safe and effective for its indicated use. However, it does not explicitly state the specific performance metrics (like sensitivity, specificity, accuracy), the thresholds for acceptance of those metrics, or the specifics of the validation study.
Therefore, I cannot populate all the requested fields from the given text. I can only infer some information based on the nature of a 510(k) submission for a clinical chemistry analyzer.
Here's what I can convey based on the provided document and general understanding of 510(k) submissions for similar devices:
1. Table of Acceptance Criteria and Reported Device Performance
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Acceptance Criteria: Not explicitly stated in the provided letter. For a clinical chemistry analyzer, acceptance criteria would typically involve demonstrating analytical performance similar to or better than a predicate device across various parameters, including:
- Accuracy: Agreement with a reference method.
- Precision (Reproducibility & Repeatability): Consistency of results.
- Linearity: Accuracy across the analytical measurement range.
- Detection Limits: Lowest concentration that can be reliably measured.
- Interference: Lack of significant impact from common interfering substances.
- Carry-over: Minimal contamination between samples.
- Stability: Reagent and calibration stability.
- Correlation: Strong correlation with predicate device or reference method.
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Reported Device Performance: Not explicitly stated in the provided letter. The 510(k) submission would have contained data supporting these performance characteristics, demonstrating that the device meets the established acceptance criteria. The FDA's clearance implies that this evidence was found satisfactory.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided letter. For a clinical chemistry analyzer, test sets would include a variety of patient samples (normal, abnormal) and spiked samples to assess different analytical aspects.
- Data Provenance: Not specified in the provided letter. Typically, clinical chemistry analyzer validation involves prospective collection of patient samples, often from multiple sites to ensure representativeness, as well as characterization of control materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts and Qualifications: Not specified in the provided letter. For clinical chemistry analyzers, "ground truth" for analytical performance is typically established through:
- Reference interval studies: Involving a statistically significant number of healthy individuals.
- Comparison studies: Against a recognized reference method or a legally marketed predicate device, where the predicate device's results serve as the comparison standard.
- Control materials and calibrators: With known, certified values.
- Analytical experts (e.g., clinical chemists, laboratory directors) would be involved in designing and overseeing these studies, and interpreting the results.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense for analytical performance of a clinical chemistry analyzer. Adjudication methods (like 2+1, 3+1) are typically used for subjective interpretations, such as image analysis or pathology review, where expert opinion is directly establishing "ground truth." For an automated analyzer, the output is quantitative, and performance is assessed against established analytical standards or comparison methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: Not applicable. MRMC studies are used to evaluate human reader performance, often with AI assistance, for tasks involving interpretation (e.g., radiology). The Olympus AU5400 is an automated clinical chemistry analyzer that produces quantitative results, not an AI-assisted diagnostic imaging tool with human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: As an automated analyzer, the device's performance is inherently "standalone" in generating the quantitative results. The entire 510(k) submission would be focused on demonstrating this standalone analytical performance. However, there's no "algorithm only without human-in-the-loop" contrast needed, as the device's function is to perform the chemical analysis automatically.
7. The Type of Ground Truth Used
- Ground Truth Type: For a clinical chemistry analyzer, the "ground truth" is typically established through:
- Reference methods: Highly accurate and validated analytical methods.
- Certified reference materials/calibrators: Materials with known, traceable analyte concentrations.
- Comparison to a legally marketed predicate device: Demonstrating equivalent performance to a device already on the market.
- Pathology/Outcomes data: Would generally not be the primary "ground truth" for the analytical performance of the analyzer itself, though the results generated by the analyzer would be used in conjunction with such data for clinical decision-making.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable in the conventional machine learning sense. This device is a traditional analytical instrument, not a machine learning or AI model that requires a "training set" to learn its function. Its operational parameters are determined by its design, engineering tolerances, and chemical principles, not by training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for a traditional clinical chemistry analyzer. The device's calibration involves using calibrator materials with known concentrations, but this is part of routine operation and quality control, not "training" in the ML sense.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
JUN 2 5 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Campbell Manager, Regulatory Affairs/Quality Assurance Olympus America Inc. 3131 West Royal Lane Irving. TX 75063-3104
510(k) Number: K011720 Re: Trade/Device Name: Olympus AU5400 Clinical Chemistry Analyzer
Regulation Number: 862.2160 862.1030 862.1035 862.1050 866.5420 866.5130 862.1070 866.3720 862.1475 862.1475 862.1100 866.5630 862.1110 862.1110 862.1145 862.1160 862.1170 862.1175 866.5240 866.5240 866.5270 862.1215 862.1215 862.1225 866.5340 862.1360 862.1345 866.5460 862.1475 866.5510 866.5510 866.5510 862.1410 862.1415 862.1440 862.1465 862.1495 866.5040 866.5680 862.1580 862.1600 866.5060 862.1635 866.5775 862.1665 866.5880 862.1705 862.1770 862.1775
Regulatory Class: II
Product Code: CIX CJE DEM JFJ GTQ JHN CIT JZG CIG CIG CIG CIG CIG CIG CHS CGZ CZW DBI DCN CGS JLB CGX DBF CFR DAD CFQ CFQ CFQ CFJ JIR DDR
CEO CEM CEK DHR JGS DDD CDQ
Regulatory Class: I
Product Code: JJE CKA LKL JHN JHN CHH JQB LBS JIY JMO CDT JGJ DDS CDT CDO
Dated: June 1, 2001 Received: June 4, 2001
Dear Mr. Campbell:
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 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.
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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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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 vou 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 at (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/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
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AU5400 510(K) Premarket Notification Submission
Indications for Use Statement
510(k) Number (if known):
Device Name:
Olympus AU5400 Clinical Chemistry Analyzer
Indications for Use:
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
(Division Sign-Off) Division of Clinical Laboratory Devices K011720 510(k) Number.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.