(17 days)
Not Found
No
The summary describes a quality control product (lyophilized human sera) for monitoring accuracy and precision of quantitative methods, with no mention of AI or ML capabilities.
No
The device is described as a quality control product used to monitor accuracy and precision for quantitative methods, not to treat or diagnose patients.
No
Explanation: The device is described as a quality control product used for monitoring accuracy and precision in quantitative methods, not for diagnosing medical conditions in patients.
No
The device description explicitly states it is a "two level quality control product consisting of lyophilized human sera," which is a physical, biological product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description mentions it's "lyophilized human sera with constituents added." This is a common format for control materials used in laboratory testing.
- Predicate Device: The predicate device listed (K992900) is also described as "Control Sera," further confirming its role in in vitro diagnostic procedures.
The purpose of this product is to ensure the reliability and accuracy of other diagnostic tests performed on patient samples, which is a core function of an IVD control material.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 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: May 7, 2004 |
| Device Name | Proprietary name: Roche Diagnostics Precinorm ® Universal and Precipath ®
Universal Control Sera
Common name: Precinorm U / Precipath U
Classification name: Multi-analyte controls, all kinds (assayed and
unassayed) |
| Device
description | 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 |
| Intended use | 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 |
| | Continued on next page |
23
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
(K992900). |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence -
Device
comparison | The table below compares Precinorm U/ Precipath U with the predicate
device (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 by
monitoring accuracy and precision
for the quantitative methods as
specified in the enclosed value sheet | Same |
| Format | Lyophilized human sera with
constituents added as required to
obtain desired component levels | Same |
| Analyte source for
albumin and total
protein methods in
Precinorm U | Human serum | Human serum and bovine
plasma albumin |
| Analyte source for
albumin and total
protein methods in
Precipath U | Human serum | Same |
| Levels | Two levels | Same |
| Stability | Lyophilized
Stable at 2-8°C until expiration date
Reconstituted:
· 2 to 8°C : 5 days
· 15 to 25 °C : 12 hours
· -15 to -25°C: 1 month (when
frozen once)
Exceptions for total and direct
bilirubin as noted in package insert. | Same |
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 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).
3
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
4
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
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