(17 days)
Precinorm ® U/ Precipath ® U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm ® U/ Precipath ® U is a two level quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels
This document is a 510(k) summary for the Precinorm® Universal and Precipath® Universal Control Sera. It is a submission for a multi-analyte control product used for quality control in quantitative laboratory methods. The submission declares substantial equivalence to a previously marketed device (K992900).
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) submission is for a quality control product, not a diagnostic device with specific performance metrics like sensitivity or specificity. The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device, primarily by showing that the modified device's characteristics (intended use, format, levels, stability) are the same, and the change in analyte source does not compromise performance.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate K992900) | Reported Device Performance (Modified Device) |
|---|---|---|
| Intended Use | For use in quality control by monitoring accuracy and precision for quantitative methods as specified in the value sheet. | Same (meets criterion) |
| Format | Lyophilized human sera with constituents added as required. | Same (meets criterion) |
| Analyte source for albumin and total protein methods in Precinorm U | Human serum. | Human serum and bovine plasma albumin (Difference noted, but deemed unsubstantial). |
| Analyte source for albumin and total protein methods in Precipath U | Human serum. | Same (meets criterion) |
| Levels | Two levels. | Same (meets criterion) |
| Stability (Lyophilized) | Stable at 2-8°C until expiration date. | Same (meets criterion) |
| Stability (Reconstituted 2-8°C) | 5 days. | Same (meets criterion) |
| Stability (Reconstituted 15-25°C) | 12 hours. | Same (meets criterion) |
| Stability (Reconstituted -15 to -25°C) | 1 month (when frozen once). | Same (meets criterion) |
| Exceptions for total and direct bilirubin | As noted in package insert. | Same (meets criterion) |
Study Proving Acceptance Criteria:
The document describes a submission seeking substantial equivalence to a predicate device (K992900). The "study" here is essentially a comparison study demonstrating that the characteristics of the modified device Precinorm U/ Precipath U are either identical to the predicate or that any differences (specifically the addition of bovine plasma albumin as an analyte source for Precinorm U) do not alter the fundamental safety or effectiveness of the device as a quality control material. The basis for substantial equivalence is listed as the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera (K992900).
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 in the given text. For a quality control product, a "test set" in the traditional sense of patient samples for diagnostic performance is not applicable. The comparison likely involved testing the modified control material against the predicate material over a range of analytes and instruments to ensure equivalent performance, but no details on sample size, data origin, or study design are given.
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 and is generally not applicable for a quality control product submission. The "ground truth" for a control material would be its assigned target values and acceptable ranges, typically established through extensive reference methods and laboratory consensus across multiple instruments and laboratories, not by a small number of experts interpreting results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for this type of submission. Adjudication methods are used in studies involving human interpretation or clinical outcomes, not typically for the characterization of a quality control product.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant for this device. This type of study is specific to diagnostic imaging devices, often involving AI, where human readers interpret medical images. This submission is for a laboratory quality control material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable for this device. This device is a biochemical control material, not a software algorithm or a device that performs a diagnostic task independently. Its "performance" is its ability to consistently produce target values and reflect the accuracy and precision of the analytical systems it is used to control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control product like Precinorm U/ Precipath U is typically established by:
- Assigned Target Values: These are derived from extensive testing using recognized reference methods and inter-laboratory studies across a range of instruments.
- Acceptable Ranges: Determined statistically from these studies to encompass expected variation for different analytical platforms.
The document does not explicitly state how the target values and ranges for these specific control sera were established, but this is the general method for such products. It certainly isn't expert consensus on clinical findings, pathology, or outcomes data, as this product is not a diagnostic test for patient samples.
8. The sample size for the training set
This is not specified and is not directly applicable in the terms of a "training set" for a machine learning algorithm. For a quality control material, the equivalent would be the number of lots, replicates, and instruments used in the characterization studies to set target values and stability claims. This detail is not provided.
9. How the ground truth for the training set was established
As in point 7 and 8, the concept of a "training set" and its "ground truth" is not directly relevant to this non-AI, non-diagnostic quality control product. The "ground truth" (i.e., the expected performance characteristics of the control material over its shelf-life) would be established through rigorous analytical testing and characterization studies, often involving multiple laboratories and instruments, to assign values and validate stability under various conditions. The document does not provide details on these specific studies, beyond stating the product's stability claims.
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MAY 27 2004
510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera
| 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) 521-3723Contact person: Theresa M. AmbroseDate prepared: May 7, 2004 |
| Device Name | Proprietary name: Roche Diagnostics Precinorm ® Universal and Precipath ®Universal Control SeraCommon name: Precinorm U / Precipath UClassification name: Multi-analyte controls, all kinds (assayed andunassayed) |
| Devicedescription | Precinorm ® U/ Precipath ® U is a two level quality control productconsisting of lyophilized human sera with constituents added as required toobtain desired component levels |
| Intended use | Precinorm ® U/ Precipath ® U is for use in quality control by monitoringaccuracy and precision for the quantitative methods as specified in theenclosed value sheet |
| Continued on next page |
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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(K992900). |
|---|---|
| SubstantialEquivalence -Devicecomparison | The table below compares Precinorm U/ Precipath U with the predicatedevice (currently marketed Precinorm U/ Precipath U). |
| Characteristic | Precinorm U/ Precipath U(Predicate device, K992900) | 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 | Lyophilized human sera withconstituents added as required toobtain desired component levels | Same |
| Analyte source foralbumin and totalprotein methods inPrecinorm U | Human serum | Human serum and bovineplasma albumin |
| Analyte source foralbumin and totalprotein methods inPrecipath U | Human serum | Same |
| Levels | Two levels | Same |
| Stability | LyophilizedStable at 2-8°C until expiration dateReconstituted:· 2 to 8°C : 5 days· 15 to 25 °C : 12 hours· -15 to -25°C: 1 month (whenfrozen once)Exceptions for total and directbilirubin as noted in package insert. | Same |
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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 lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 7 2004
Theresa M. Ambrose, Ph.D. RAC Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K041227 Re:
Trade/Device Name: Precinorm ® Universal and Precipath ® Universal Control Sera Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assay and unassayed) Regulatory Class: Class I Product Code: JJY Dated: May 7, 2004 Received: May 10, 2004
Dear Dr. Ambrosc:
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 docs 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).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma lotter with and in your finding of substantial equivalence of your device to a legally promation hotel noticated 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 you destions 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 Four may 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):
Precinorm ® Universal and Precipath ® Universal Control Sera Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Precinorm U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath U is for use in quality quantitative methods as specificul in the cholorous value in 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)
Carol C. Benson
vision Sign-Off
fice of In Vitro Diagnostic Device valuation and Safety
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510(k) K041227
21
§ 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.