(31 days)
Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are intended for use as a control in the immunoturbidimetric assay of serum proteins. It is well suited for automated analytical procedures. The assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems.
Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are a two-level liquid preparation of pooled human sera with constituents in the normal (Precinorm ® Protein) and pathological (Precipath ® Protein) ranges.
The provided document is a 510(k) summary for the Boehringer Mannheim Precinorm® Protein Precipath® Protein Controls. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, many of the requested details such as acceptance criteria, specific study design, sample sizes for test and training sets, number and qualifications of experts, the type of ground truth, and effects of AI assistance are not available in this document. The device is a quality control material intended to ensure the accuracy of immunoturbidimetric assays for serum proteins, not a diagnostic algorithm that would typically have these types of performance metrics.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. The summary focuses on comparing the new device to predicate devices rather than defining specific performance acceptance criteria and then showing data that meets them. The device's performance is implicitly evaluated by its suitability for "use as a control in the immunoturbidimetric assay of serum proteins" and its "assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems."
2. Sample size 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. The document does not describe a performance study with a test set in the typical sense for a diagnostic device.
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. As this is a control material, "ground truth" would likely refer to the target values of the constituents, which are established during the manufacturing process and assigned using specific analytical systems. Experts in clinical interpretation for ground truth are not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are not applicable to the evaluation of a quality control material.
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:
This is not applicable to this device. This device is a control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this device. This device is a control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as it applies to an imaging or diagnostic algorithm is not relevant here. For a quality control material, the "ground truth" would be the assigned values (target concentrations) for each protein constituent within the control. These values are established through rigorous analytical testing during the manufacturing process, typically using reference methods or the specified analytical system (Boehringer Mannheim/Hitachi systems as mentioned in the "Indications for Use").
8. The sample size for the training set:
This information is not provided. The document doesn't describe a "training set" in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established:
This information is not provided. As above, the concept of a "training set" and associated ground truth establishment is not relevant for this type of device.
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MAY 18 1998
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510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Boehringer Mannheim Corporation9115 Hague RdIndianapolis, IN 46250(317) 576-3723 |
| Contact person: Priscilla A. Hamill | |
| Date prepared: April 1, 1998 | |
| 2) Device name | Proprietary name: Boehringer Mannheim Precinorm ® Protein Precipath ®Protein Controls |
| Common name: Precinorm ® Protein Precipath ® Protein Controls | |
| Classification name: Multi-analyte Controls, All Kinds (assayed andunassayed) | |
| 3) Predicatedevice | We claim substantial equivalence to Precinorm ® Protein control (K871027)and Precipath® Protein (K933589) control |
| 4) Devicedescription | Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls area two-level liquid preparation of pooled human sera with constituents in thenormal (Precinorm ® Protein) and pathological (Precipath ® Protein) ranges. |
| Continued on next page |
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510(k) Summary, Continued
- Intended use Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are intended for use as a control in the immunoturbidimetric assay of serum proteins. 6) Comparison Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are to the predicate substantially equivalent to other products in commercial distribution intended device for similar use. Most notably, it is substantially equivalent to the currently Precinorm ® Protein and Precipath ® Protein controls marketed by Boehringer Mannheim Corporation. These controls were cleared by the FDA based on a 510(k) submissions by Boehringer Mannheim. The 510(k) number for the Precinorm ® Protein submission is K871027. The 510(k) number for the Precipath ® Protein submission is K933589. The intended use of this BM control and the predicate devices is the same in that they are intended to be used for the control of immunoturbidimetric assay of serum proteins. The only significant difference is the inclusion of additional constitutent analytes.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 8 1998
Patricia A. Hamill · Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K981401 Re : Precinorm® Protein Precipath® Protein Controls Requlatory Class: I Product Code: JJY Dated: April 15, 1998 Received: April 17, 1998
Dear Ms. Hamill:
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 arr 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਰੇ 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 requlatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2
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 Other qeneral 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/dsmamain.html".
Sincerely yours,
Steven Litman
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): ____________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls
Indications for Use: For use as a control in the immunoturbidimetric assay of serum proteins. It is well suited for automated analytical procedures. The assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981401 |
|---|---|
| --------------- | --------- |
§ 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.