(20 days)
OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.
OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.
The provided document is a 510(k) Notification for the OPUS hLH Controls, a quality control material, not an AI/ML powered device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of medical device submission.
However, I can extract information related to the device performance characteristics, which serve as the acceptance criteria for this quality control material.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Device Performance |
|---|---|
| Intra-assay Precision (Overall %CV) | Ranged from 4.51% to 6.48% (for three levels of control material) |
| Inter-assay Precision (Overall %CV) | Ranged from 2.48% to 6.41% (for three levels of control material) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Intra-assay precision: 20 replicates for each of the three levels of control material (total of 60 measurements).
- Inter-assay precision: Duplicate measurements over a five-day period, totaling 20 replicates for each of the three levels of control material (total of 60 measurements).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is a submission for a quality control material, and such studies are typically performed in a controlled laboratory setting by the manufacturer (Dade-Behring Inc., located in Westwood, MA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control material. Its "ground truth" (i.e., expected LH levels) is established during its manufacturing and assay process, not by expert review of patient data. The study focuses on the precision of the control material when run on an analyzer.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication for the performance of a quality control material. The performance is assessed purely based on statistical precision metrics.
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 quality control material, not an AI/ML-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a quality control material for an immunoassay, not an algorithm.
7. The type of ground truth used
For quality control materials, the "ground truth" refers to the target or assigned values for the analytes within the control. These are established through:
- Manufacturer's internal assays: Batch testing during production to determine the concentration of hLH at each control level.
- Assigned values: The control material is "assayed," meaning it comes with lot-specific values, likely determined by the manufacturer against a reference method or standard.
The study then assesses how precisely the OPUS hLH assay measures these known levels within the control material.
8. The sample size for the training set
Not applicable. Quality control materials do not typically have a "training set" in the context of AI/ML or classification algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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K9138832
510(k) Notification Dade-Behring Inc. OPUS hLH Controls
OCT 27 1997
Summary for 510(k) OPUS hLH Controls
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Manufacturer:
Dade-Behring Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt
Preparation date:
October 6, 1997
Device Name/ Classification: 2 .
OPUS hLH Controls: Classification Number: Quality Control Material Class | (862.1660)
Identification of the legally marketed device: 3 .
OPUS® hCG
Device Description: 4 . Proposed
OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.
Proposed Device Intended Use: 5 .
OPUS hLH controls are intended for use as an assayed quality control material in the clinical laboratory to assess or verify the performance of the OPUS hLH assay.
6 . Medical device to which equivalence is claimed and comparison information:
The OPUS hLH Controls are substantially equivalent in intended use to the OPUS hCG Controls. Both products arein vitro diagnostic reagents intended for use as a quality control material to monitor specific laboratory procedures. The OPUS hLH Controls, like the OPUS hCG Controls, are a tri-level serum-based matrix controls for specific OPUS assays only. Both controls are provided with lot specific values for the Behring OPUS Immunoassay System.
The OPUS hLH Controls differ from the OPUS hCG Controls in that the OPUS hLH Controls are for use with the OPUS hLH assay and contain known levels of LH, while the OPUS hCG Controls are for use with the OPUS hCG assay and contain known levels of hCG.
Image /page/0/Picture/21 description: The image contains the word "CONFIDENTIAL" in large, bold, black letters. The word is written in all capital letters and is slightly angled upwards from left to right. The font appears to be a sans-serif typeface, and the overall impression is one of emphasis and importance.
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510(k) Notification Dade-Behring Inc. OPUS hLH Controls
7. Device Performance Characteristics:
Precision
Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 4.51% to 6.48%.
Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 2.48% to 6.41%.
CONFIDENTIAL
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 7 1997
Ruth Forstadt . Regulatory Affairs Associate Behring Diagnostics, Inc. 151 University Avenue Westwood, Massachusetts 02090
Re : K973832 OPUS hLH Controls Requlatory Class: I Product Code: JJX Dated: October 6, 1997 Received: October 7, 1997
Dear Ms. Forstadt:
requlations.
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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (OS) 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
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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 requlation (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 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.qov/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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510(k) Notification Dade-Behring Inc. OPUS hLH Controls
Page of
510(k) Number (if known): J
Device Name:_
OPUS hLH Controls
Indications For Use:
OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973832
Prescription Use_y (Per 21 CFR 801.109)
PAFIDENTIAL
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
00000
§ 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.