(29 days)
For the monitoring and control of processes for measuring the lipoproteins, HDL-C and LDL-C.
lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol.
The provided 510(k) summary for the Boehringer Mannheim Precipath® HDL/LDL-C Control is for a multi-analyte control device, not a diagnostic or prognostic algorithm. Therefore, many of the requested criteria related to algorithm performance, such as sensitivity, specificity, MRMC studies, and ground truth establishment from patient data, are not applicable.
The document primarily focuses on establishing substantial equivalence to a predicate device (Sigma Diagnostics Cardiolipid™ Controls) for its intended use: monitoring and control of processes for measuring HDL-C and LDL-C.
Here's an attempt to address the relevant points based on the provided text, and indicating where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Monitoring and control of processes for measuring HDL-C and LDL-C. | Substantially Equivalent: "The intended use of this BM control and the predicate devices is the same in that they are intended to be used for the monitoring and control of test systems for the measurement of their labeled analytes." |
| Device Composition: Lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol. | Matches Description: "The Boehringer Mannheim Precipath® HDL/LDL-C Control consists of lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol." Implicitly, this composition is considered acceptable and equivalent to the predicate. |
Study Proving Device Meets Acceptance Criteria:
The document doesn't detail a specific "study" in the sense of a clinical trial or performance evaluation with statistical metrics for the control device itself. Instead, the acceptance criterion for regulatory clearance is based on demonstrating substantial equivalence to a predicate device. The primary "proof" is the comparison to the predicate device (Sigma Diagnostics Cardiolipid™ Controls), where the applicant asserts that the intended use and device characteristics are similar.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable for a control device. Control devices are used to monitor the performance of other diagnostic assays; they are not themselves tested against a clinical "test set" of patient samples in the same way an algorithm or diagnostic test would be. The "sample" here refers to the manufacturing batch of the control solution itself, and its consistency across batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no "test set" or diagnostic ground truth being established for this control device. The performance of the control is a measure of its stability and consistency in providing known analyte levels, not its ability to diagnose a condition.
4. Adjudication Method for the Test Set
Not applicable for a control device.
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 is a quality control material and not an AI-powered diagnostic tool, nor does it involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laboratory control material, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of diagnostic ground truth. The "ground truth" for a control material would be the certified or established concentration of HDL-C and LDL-C within the control material itself, determined through reference methods or highly accurate analytical techniques during its manufacturing and characterization. The document does not detail how these internal "ground truths" (i.e., the labeled values) for the control were established.
8. The Sample Size for the Training Set
Not applicable. This is a control material, not an algorithm trained on data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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510(k) Summary
JAN 22 1998 K9774826
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
Boehringer Mannheim Corporation 1) Submitter name, address, 9115 Hague Rd contact Indianapolis, IN 46250 (317) 845-2386
Contact person: Edward R. Kimmelman
Date prepared: Dec. 23, 1997
- Device name Proprietary name: Boehringer Mannheim Precipath® HDL/LDL-C
Common name: BM Precipath® HDL/LDL-C
Classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassaved)
- Predicate We claim substantial equivalence to the Sigma Diagostics Cardiolipid™ device Controls. The intended use of the above controls is monitoring and control of processes for measuring the lipoproteins. HDL-C and LDL-C.
The Boehringer Mannheim Precipath® HDL/LDL-C Control consists of 4) Device description lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol.
The Boehringer Mannheim Precipath® HDL/LDL-C Control is intended to be 5) Intended use used in the monitoring and control of processes for measuring HDL-C and LDL-C.
Continued on next page
11:43
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510(k) Summary, Continued
The Boehringer Mannheim Precipath® HDL/LDL-C control is substantially 6) Comparison equivalent to other products in commercial distribution intended for similar to the predicate device use. Most notably, it is substantially equivalent to the currently marketed Sigma Diagnostics Cardiolipid™ Controls.
The intended use of this BM control and the predicate devices is the same in that they are intended to be used for the monitoring and control of test systems for the measurement of their labeled analytes.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 2 1998
Edward R. Kimmelman · Program Director, Regulatory Affairs and Compliance Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250
K974826 Re: Precipath® HDL/LDL-C Control Requlatory Class: I JJY, LBS Product Code: Dated: December 23, 1997 Received: December 24, 1997__ _ - -
Dear Mr. Kimmelman:
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 The general controls provisions of the Act 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 requlations 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.
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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 Also, please note the Office of Compliance at (301) 594-4639. 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 (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 Precipath® HDL/LDL-C Control
Indications for Use: For the monitoring and control of processes for measuring the lipoproteins, HDL-C and LDL-C.
(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)
vision of Clinical Laboratory Device:
510(k) Number. K974826
16
§ 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.