(21 days)
Not Found
No
The 510(k) summary describes a liquid quality control material for laboratory tests, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as a quality control material for monitoring accuracy and precision in quantitative laboratory methods, not for treating a condition or disease.
No
This device is a quality control material used for monitoring the accuracy and precision of quantitative laboratory methods, not for diagnosing diseases in patients.
No
The device description clearly states it is a "liquid ready-for-use control based on a buffered aqueous solution," indicating it is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet." This indicates it is used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It is described as a "liquid ready-for-use control based on a buffered aqueous solution." Control materials are a common type of IVD used to verify the accuracy and precision of diagnostic assays.
- Predicate Device: The presence of a predicate device (K040280) which is described as "Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera" further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and in this case, the predicate is clearly an IVD control material.
The lack of information regarding image processing, AI/ML, anatomical site, patient age, user, training/test sets, performance studies, and key metrics is typical for a quality control material, as its primary function is to assess the performance of other diagnostic devices, not to directly diagnose or treat patients.
N/A
Intended Use / 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.
Product codes
JJY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd
Indianapolis 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 and
unassayed) |
| Device
description | 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. |
| Intended use | Precinorm ® PUC/ Precipath ® PUC is for use in quality control by
monitoring accuracy and precision for the quantitative methods as specified in
the enclosed value sheet |
| | Continued on next page |
23
ﮨﮯ
1
510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued
| Substantial
Equivalence | Roche claims substantial equivalence to the currently marketed Roche
Diagnostics Precinorm® Universal and Precipath® Universal Control Sera
(K040280). |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence –
Device
comparison | The table below compares Precinorm® PUC / Precipath® PUC with the
predicate 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 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 |
2
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
3
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
4
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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