(13 days)
The Boehringer Mannheim Precinorm and Precipath® RF Controls are used for the quality control of the Boehringer Mannheim Tinaquant RF assay.
The Boehringer Mannheim Precinorm and Precipath® RF Controls are manufactured using human serum albumin, Rheumatoid Factor, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.
Here's an analysis of the provided text regarding the Boehringer Mannheim Precinorm and Precipath® RF Controls:
Acceptance Criteria and Device Performance Study
Based on the provided document, the device described is a quality control product for an assay, not a diagnostic device that directly measures a patient's condition. As such, the typical metrics for diagnostic devices (sensitivity, specificity, AUC) or AI-powered devices are not applicable or described in this submission.
The "acceptance criteria" for this type of product are focused on its performance as a control material, primarily its ability to provide consistent and accurate values for quality control of the associated assay and its equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | "Substantially equivalent to other products in commercial distribution intended for similar use." (Specifically, Behring N/T Rheumatology Control SL1, SL2 (K962373)) |
| Matrix Equivalence | "Similar matrix" to the predicate. |
| Dose Assignment | "Equivalent performance to the predicate device." |
| Stability | "Equivalent performance to the predicate device." |
| Manufacturing Process | "The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator." |
| Analyte Inclusion | Contains Rheumatoid Factor for its intended assay. |
Study Details:
The document describes a 510(k) premarket notification for a new quality control product. The "study" presented is primarily a comparison of the new device to a predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance study with a large patient cohort in the traditional sense of a diagnostic device.
- Type of Study: Substantial Equivalence Comparison. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed predicate device.
- Proof of Equivalence: The document states, "Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5." However, this attachment with the specific performance data is not provided in the given text. The summary only gives high-level statements about "equivalent performance."
Further Breakdown based on the provided text:
2. Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "specific data on the performance of the controls" being in an attachment not provided. For a control material, this "test set" would likely involve multiple lots of the control, run across various instruments and reagent lots of the associated assay (Boehringer Mannheim Tinaquant RF assay).
- Data Provenance: Not specified, but generally, such comparison studies are conducted internally by the manufacturer. It's prospective in the sense that the new control material is evaluated against established methods and predicate controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense for this product. For a quality control material, the "ground truth" for its performance is typically established through reference methods, certified reference materials, and rigorous internal validation processes by qualified laboratory personnel, not expert clinical consensus on patient data. The "value assignment process" mentioned is how the expected values for the control are determined.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used when there's ambiguity in clinical interpretations or diagnostic outcomes. For a quality control material, performance is evaluated against predefined statistical limits and comparative analysis to a predicate.
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:
- No. This is not an AI-powered diagnostic device, and therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical control material, not an algorithm.
7. The type of ground truth used:
- For the Precinorm and Precipath® RF Controls themselves: The "ground truth" (or target values) for the control material's analytes would be established through a "value assignment process" referenced in the description. This process involves "comparison to an analyte specific (and chemistry specific) calibrator." This implies a traceability to reference standards or highly characterized reference materials.
- For proving substantial equivalence: The predicate device's established performance and intended use serve as a comparative "ground truth."
8. The sample size for the training set:
- Not applicable. This product does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is used.
{0}------------------------------------------------
OCT - 7 1997
| BOEHRINGERMANNHEIM SummaryORPORATION | Image: boehringer logo | |
|---|---|---|
| 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 Corporation4300 Hacienda DrivePleasanton, CA. 94588-2722(510) 730-8413Contact Person: Yvette LloydDate Prepared: September 19, 1997 | |
| 2.Device Name | Proprietary name: Precinorm and Precipath® RF ControlsCommon name: ControlsClassification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3.Predicatedevice | The Boehringer Mannheim Precinorm and Precipath® RF Controls are a newproduct.The Boehringer Mannheim Precinorm and Precipath® RF Controls aresubstantially equivalent to other products in commercial distribution intendedfor similar use. Most notably it is substantially equivalent to the Behring N/TRheumatology Control SL1, SL2 (K962373). | |
| 4.DeviceDescription | The Boehringer Mannheim Precinorm and Precipath® RF Controls aremanufactured using human serum albumin, Rheumatoid Factor, andstabilizers. The analyte is appropriately spiked into the control matrix to thecorrect control concentration levels. The controls are in process checked, and avalue assignment process is done via a comparison to an analyte specific (andchemistry specific) calibrator. |
{1}------------------------------------------------
| Summary, Continued | |
|---|---|
| -- | -------------------- |
| 5.Intended use | The Boehringer Mannheim Precinorm and Precipath® RF Controls are usedfor the quality control of the Boehringer Mannheim Tinaquant RF assay. |
|---|---|
| 6.Comparisonto predicatedevice | The Boehringer Mannheim Precinorm and Precipath® RF Controls aresubstantially equivalent to other products in commercial distribution intendedfor similar use. Most notably it is substantially equivalent to the Behring N/TRheumatology Control SL1, SL2 (K962373). |
The following table compares the Boehringer Mannheim Precinorm® TDM
Controls with the predicate device, the Behring N/T Rheumatology Control
SL1, SL2. Specific data on the performance of the controls have been
incorporated into the draft labeling in attachment 5. Labeling for the predicate
devices are provided in attachment 6..
Similarities:
- Similar intended use
- Similar matrix
Continued on next page
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a logo with the word "mannheim" written vertically on the left side of a black rectangle. Inside the rectangle is a white circle with the word "boehringer" written in the center. The logo appears to be for a company called "Boehringer Mannheim".
Differences:
| Feature | Precinorm/Precipath ® RF Control | Behring N/T Rheumatology Control SL1/SL2 |
|---|---|---|
| Analytes | Rheumatoid Factor | Rheumatoid Factor, ASL, CRP |
| ReconstitutionInstructions | Add 1 mL of distilled water, then letdissolve with occasional swirling. | Ready for use (liquid stable) |
Performance Characteristics:
6. Comparison to predicate device, (cont.)
· Dose assignment and stability: equivalent performance to the predicate device.
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 7 1997
Ms. Yvette Lloyd Regulatory Affairs Specialist Boehringer Mannheim Corporation 4300 Hacienda Drive Pleasanton, California 94588-2722
Re : K973629 Precinorm and Precipath® RF Controls Trade Name: Requlatory Class: I Product Code: JJY Dated: September 22, 1997 Received: September 24, 1997
Dear Ms. Lloyd:
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, listinq of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Failure to comply with the GMP regulation may result in assumptions. 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.
{4}------------------------------------------------
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 leqally 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 requlation 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 Putman
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
{5}------------------------------------------------
| 510(k) Number (if known): | 7973647 |
|---|---|
| Device Name: | Precinorm & Precapath RF Controls |
| Indications For Use: |
The Precinorm and Precipath® RF Controls are used for the quality control of the Boehringer Mannheim Tinaquant Rheumatoid Factor assay.
(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
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
ﺎ
. f
§ 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.