(21 days)
Precinorm ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® and proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm ® PUC/ Precipath ® PUC is a liquid ready-for-use control based on a buffered aqueous solution. Concentrations of control components have been adjusted to represent normal and pathological ranges.
The provided 510(k) summary (K041812) describes a quality control material (Precinorm® Proteins in Urine/CSF (PUC) and Precipath® Proteins in Urine/CSF (PUC)), not an AI/ML powered device. As such, the concept of "acceptance criteria," "study that proves the device meets acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set size," and "ground truth for training set" in the context of AI/ML performance metrics are not applicable to this submission.
This submission is for a quality control material, which is a diagnostic product used to monitor the performance of laboratory tests. The summary focuses on demonstrating "substantial equivalence" to a predicate device, as required for 510(k) submissions.
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, etc., and "reported device performance" are not applicable here. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device in terms of intended use, format, stability, and constituent analytes.
| Characteristic | Precinorm® U/ Precipath® U (Predicate device, K040280) | Precinorm® U/ Precipath® U (Modified Device) |
|---|---|---|
| Intended Use | For use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet | Same |
| Format | Liquid ready-for-use control based on a buffered aqueous solution. Concentrations of control components have been adjusted to represent normal and pathological ranges. | Same |
| Stability | Unopened: Stable at 2-8°C until expiration date. Opened: Stable at 2 to 8°C for 4 weeks. | Same |
| Constituent Analytes with Assigned Values | Precinorm • Albumin • Creatinine • Total Protein Precipath • Albumin • • Creatinine • Total Protein | Precinorm Same Precipath • Albumin • Creatinine • Total Protein • Immunoglobulin A • Immunoglobulin M |
The "reported device performance" is the claim that the modified device is "substantially equivalent" to the predicate device based on these characteristics. The key difference noted is the addition of Immunoglobulin A and Immunoglobulin M to Precipath®. The assumption is that the new formulation maintains similar performance characteristics for the common analytes and that the new analytes perform as expected for a quality control material.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study assessing diagnostic accuracy with a test set of patient data, but rather a submission for a quality control material. No patient samples or clinical data are mentioned for establishing performance.
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)
Not applicable. Ground truth as typically understood in AI/ML is not relevant for this type of device. The "ground truth" for a quality control material is its accurately assigned values for the analytes it controls, which would be established through robust analytical methods by the manufacturer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set of patient data is mentioned or relevant.
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 not an AI-powered diagnostic device, and therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical quality control material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this device would be the accurately determined concentrations of the analytes within the control material, established through analytical laboratory methods, not clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, and no training set is used.
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JUL 2 7 2004
510(k) Summary - Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® Proteins in Urine/CSF (PUC)
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence |
|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3723 |
| Contact person: Theresa M. Ambrose | |
| Date prepared: July 2, 2004 | |
| Device Name | Proprietary name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ®Proteins in Urine/CSF (PUC) |
| Common name: Precinorm ® PUC/ Precipath ® PUC | |
| Classification name: Multi-analyte controls, all kinds (assayed andunassayed) | |
| Devicedescription | Precinorm ® PUC/ Precipath ® PUC is a liquid ready-for-use control basedon a buffered aqueous solution. Concentrations of control components havebeen adjusted to represent normal and pathological ranges. |
| Intended use | Precinorm ® PUC/ Precipath ® PUC is for use in quality control bymonitoring accuracy and precision for the quantitative methods as specified inthe enclosed value sheet |
| Continued on next page |
23
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510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued
| SubstantialEquivalence | Roche claims substantial equivalence to the currently marketed RocheDiagnostics Precinorm® Universal and Precipath® Universal Control Sera(K040280). |
|---|---|
| SubstantialEquivalence –Devicecomparison | The table below compares Precinorm® PUC / Precipath® PUC with thepredicate device (currently marketed Precinorm® PUC / Precipath® PUC). |
| Characteristic | Precinorm U/ Precipath U(Predicate device, K040280) | Precinorm U/ Precipath U(Modified Device) |
|---|---|---|
| Intended Use | For use in quality control bymonitoring accuracy and precisionfor the quantitative methods asspecified in the enclosed value sheet | Same |
| Format | Liquid ready-for-use control basedon a buffered aqueous solution.Concentrations of controlcomponents have been adjusted torepresent normal and pathologicalranges. | Same |
| Stability | UnopenedStable at 2-8°C until expiration dateOpened:Stable at 2 to 8°C for 4 weeks | Same |
| Constituent Analyteswith Assigned Values | Precinorm• Albumin• Creatinine• Total ProteinPrecipath• Albumin• Creatinine• Total Protein | PrecinormSamePrecipath• Albumin• Creatinine• Total Protein• Immunoglobulin A• Immunoglobulin M |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Theresa M. Ambrose, PhD RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K041812 Re:
Trade/Device Name: Precinorm® Proteins in Urine/ CSF (PUC) Precipath ® Proteins in Urine/ CSF (PUC) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 2, 2004 Received: July 6, 2004
Dear Dr.. Ambrose:
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 device 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 of 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).
JUL 27 2004
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Ko41812
Device Name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® Proteins in Urine/CSF (PUC)
Indications For Use:
Precinorm ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® and proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Prescription Use X (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)
Alberts
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) t0418(2
§ 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.