(14 days)
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm CK-MB is a lyophilized controls based on bovine serum albumin. Adjusted activities of the control components are usually in the normal range or at the normal/pathological threshold. Precipath CK-MB is a lyophilized controls based on bovine serum albumin. Adjusted activities of the control components are usually in the pathological range. Biological additives for both control levels include CK-MM from human origin and CK-BB from porcine brain.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Precinorm CK-MB & Precipath CK-MB controls, structured to meet your request.
Please Note: The provided document is a 510(k) summary for a "Special 510(k): Device Modification" for quality control materials. As such, it describes modifications to existing controls and their intended use in monitoring the accuracy and precision of other diagnostic methods. Therefore, the types of studies you'd typically see for a diagnostic device (e.g., clinical trials with human subjects, ground truth established by pathology or outcomes data) are not applicable here. Instead, the "device performance" relates to the control's ability to maintain its specified analyte levels and stability, and the "study" is more akin to a verification and validation of these characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria | Reported Device Performance/Study Findings |
|---|---|
| Intended Use: Precinorm CK-MB: monitoring accuracy and precision for quantitative methods (normal range or normal/pathological threshold).Precipath CK-MB: monitoring accuracy and precision for quantitative methods (pathological range). | The modifications (new name Precipath CK-MB with existing concentration, and new Precinorm CK-MB with reduced levels) are intended to continue to fulfill the use case of monitoring accuracy and precision for quantitative methods. The application emphasizes substantial equivalence to the predicate device in terms of intended use, with the primary change being the introduction of a control covering the normal range. |
| Analyte Level (Active Ingredient Level): Precinorm CK-MB: CK and CK-MB usually at normal range or at the normal/pathological threshold. Precipath CK-MB: CK and CK-MB usually at pathological level. | These are the stated characteristics of the modified devices. The value assignment process described below is the study that establishes these levels. |
| Stability (Shelf Life & Open Vial): 2-8 °C until expiration dateReconstituted: 24 hours at 25° C, 3 days at 4° C, 1 month at -20° C (freeze only once). | The "Same" entry in the "Modified device" column for stability and shelf life compared to the predicate device (K003158) indicates that the modified controls meet the same stability criteria as the predicate. The document implies that stability studies for the modified formulations confirmed these specifications, as it explicitly states the predicate's performance and then claims "Same" for the modified device. |
| Traceability of Target Values: Traceability given in instructions for use of the system reagent with recommended calibrator. | "Same" as the predicate device. This implies that the method for ensuring traceability of the assigned values to reference standards is consistent with the previously cleared device. |
| Value Assignment (Accuracy/Precision of Control Values): Set-point established via mean of at least three independent series in three internal laboratories, each with full calibration. | The "Value Assignment" process is detailed as: - Conducted in three internal laboratories. - Each laboratory runs at least three independent series. - An independent series includes full calibration using a new calibrator vial and sample vial. - The mean of these measurements is used as the setpoint (assigned value) for the control. - The master calibrator is used for calibration. This process ensures the accuracy and precision of the assigned values for the control material itself. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: For the "Value Assignment" study, the sample size is described as "at least three independent series" over "three internal laboratories." This means a minimum of 9 independent measurements (3 labs * 3 series/lab) would be performed to establish the mean setpoint for each control level (Precinorm CK-MB and Precipath CK-MB) and each analyte (CK and CK-MB).
- Data Provenance: The data is generated from prospective testing within Roche Diagnostics' internal laboratories. The country of origin is not explicitly stated, but Roche Diagnostics is headquartered in Switzerland, with the submitting entity located in Indianapolis, IN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: This isn't applicable in the traditional sense of human expert review for "ground truth" for a diagnostic device. The "ground truth" here is the assigned value of the control material, representing a specific and known concentration of the analyte.
- Qualifications of Experts: The "experts" involved are the laboratory personnel performing the "Value Assignment" in the three internal laboratories. Their qualifications are implied by their ability to operate the analytical instruments, perform calibrations, and execute the value assignment protocol according to internal standards and good laboratory practices. The document does not specify individual qualifications (e.g., "clinical chemist with X years of experience").
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of expert adjudication. The "adjudication" of the control's value is purely statistical: "The mean is used as setpoint." This means the results from the different independent series and laboratories are averaged to determine the final assigned value for the control. There's no human consensus or tie-breaking process described beyond the statistical aggregation.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Precinorm CK-MB & Precipath CK-MB controls are laboratory reagents used to monitor the performance of analytical instruments, not for human interpretation of clinical cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. These are physical control materials, not an algorithm. Their "performance" is based on their biochemical properties and the accuracy/precision of their assigned values, which are verified through laboratory testing.
7. The Type of Ground Truth Used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for the test set (the control material itself) is its assigned value, established through a rigorous value assignment process involving multiple measurements across multiple laboratories and traceable to reference methods/calibrators. This is an analytical/statistical ground truth based on quantitative chemical measurement, not a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. These are quality control materials, not an AI or machine learning algorithm that requires a "training set." The materials are manufactured to a specification, and their assigned values are verified, not learned.
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 quality control material.
{0}------------------------------------------------
K062972
OCT 13 2006
510(k) Summary–Precinorm CK-MB & Precipath CK-MB
| Introduction | Roche Diagnostics Corporation hereby submits this Special 510(k): DeviceModification to provide notification of modifications to our Precinorm CK-MB Control. This control was originally cleared for use in K003158, alongwith a CK-MB reagent and calibrator system on Roche/Hitachi Analyzers. | ||
|---|---|---|---|
| Modifications to the control include: | |||
| Change of name for Precinorm CK-MB to Precipath CK-MB (nochange of analyte concentration), andNew, additional control level with reduced levels of CK and CK-MBto normal levels. This new level is now called Precinorm CK-MB. | |||
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-7637Contact person: Kerwin KaufmanDate prepared: September 28, 2006 | ||
| Device Name | Proprietary name: Precinorm CK-MB and Precipath CK-MB ControlsCommon name: Single (Specified) Analyte Controls (assayed and unassayed)Classification name: Quality control material (assayed and unassayed) | ||
| DeviceDescription | Precinorm CK-MB is for use in quality control by monitoring accuracy andprecision for the quantitative methods as specified in the enclosed value sheet.Precipath CK-MB is for use in quality control by monitoring accuracy andprecision for the quantitative methods as specified in the enclosed value sheet.Precinorm CK-MB is a lyophilized controls based on bovine serum albumin.Adjusted activities of the control components are usually in the normal rangeor at the normal/pathological threshold. Precipath CK-MB is a lyophilizedcontrols based on bovine serum albumin. Adjusted activities of the controlcomponents are usually in the pathological range. Biological additives forboth control levels include CK-MM from human origin and CK-BB fromporcine brain. | ||
| Intended use | Precinorm CK-MB is for use in quality control by monitoring accuracy andprecision for the quantitative methods as specified in the enclosed value sheet. | ||
| Precipath CK-MB is for use in quality control by monitoring accuracy andprecision for the quantitative methods as specified in the enclosed value sheet. | |||
| Predicate | We claim substantial equivalence to the Precinorm CK-MB control cleared in | ||
| Device | K003158. | ||
| Substantial | The table below indicates the similarities and differences between the | ||
| equivalency - | modified Precinorm CK-MB control and its predicate device (Precinorm CK- | ||
| Similarities/Diff | MB, K003158). Note that the predicate device is now sold as Precipath CK- | ||
| erences | MB (no change in analyte concentration) as described above. |
.
Continued on next page
{1}------------------------------------------------
510(k) Summary–Precinorm CK-MB & Precipath CK-MB,
Continued
| Feature | Predicate device:Precinorm CK-MB(K003158) | Modified device:Precinorm CK-MB andPrecipath CK-MB |
|---|---|---|
| Intended Use(from labeling) | Precinorm CK-MB is for use in thequality control of Roche methods forthe quantitative determination ofCK-MB and creatine kinaseactivities. The control is used formonitoring accuracy and precisionboth for manual techniques and forassays on clinical chemistryanalyzers. | Precinorm CK-MB is for use inquality control by monitoringaccuracy and precision for thequantitative methods as specified inthe enclosed value sheet.Precipath CK-MB is for use inquality control by monitoringaccuracy and precision for thequantitative methods as specified inthe enclosed value sheet. |
| Reagentcomposition | Lyophilized control serum based onbovine serum albumin withchemical additives and material ofbiological origin. | Same |
Continued on next page
{2}------------------------------------------------
510(k) Summary–Precinorm CK-MB & Precipath CK-MB, Continued
| Feature | Predicate device:Precinorm CK-MB(K003158) | Modified device:Precinorm CK-MB andPrecipath CK-MB |
|---|---|---|
| ActiveIngredient Level | Precinorm CK-MB:CK and CK-MB usually atpathological level | Precinorm CK-MB:CK and CK-MB usually at normalrange or at the normal/pathologicalthreshold.Precipath CK-MB:CK and CK-MB usually atpathological level |
| Stability - shelflife and open vial | 2-8 °C until expiration dateReconstituted:24 hours at 25° C3 days at 4° C1 month at -20° C (freeze only once) | Same |
| Traceability | Traceability of the target values isgiven in the respective instructionsfor use of the system reagent to beused in combination with therecommended calibrator. | Same |
| ValueAssignment | The value assignment takes place inthree internal laboratories. Eachlaboratory runs at least threeindependent series. An independentseries includes full calibration usinga new calibrator vial and samplevial. The mean is used as setpoint.Controls which have to be assignedare used as samples. The mastercalibrator is used for calibration. | Same |
Substantial equivalency – Similarities/Differences (continued)
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 2006
Mr. Kerwin Kaufman Roche Diagnostics PO Box 50457 9115 Hague Rd Indianapolis, IN 46250
Re:
K062972 Trade/Device Name: Precinorm CK-MB and Precipath CK-MB Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: September 28, 2006 Received: September 29, 2006
Dear Mr. Kaufman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your revire can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements aft the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Precinorm CK-MB and Precipath CK-MB Controls
Indications For Use:
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K062972
§ 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.