(25 days)
Not Found
No
The document describes calibrators and controls for clinical chemistry analyzers, which are standard laboratory reagents and do not inherently incorporate AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device descriptions indicate that these products are calibrators and controls used for quality control and calibration of quantitative methods on clinical chemistry analyzers, not for treating diseases or conditions.
No
The device is described as a calibrator and quality control material for quantitative Roche clinical chemistry analyzers, monitoring accuracy and precision. It does not perform diagnostic functions itself.
No
The device description clearly states it is a liquid, ready-for-use calibrator/control consisting of a buffered aqueous solution with biological materials, indicating it is a physical reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the products are for use in the calibration and quality control of quantitative Roche methods on clinical chemistry analyzers. This indicates that the products are used to analyze samples in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description of the products as calibrators and controls used in a laboratory setting further supports their classification as IVDs.
- Predicate Devices: The listing of predicate devices (K040264, C.f.a.s. PUC; K041812, Roche Diagnostics Precinorm ® PUC and Precipath ® PUC) which are also IVDs, strongly suggests that this device falls into the same category.
The lack of information regarding image processing, AI/ML, imaging modality, anatomical site, patient age range, intended user, training/test sets, performance studies, and key metrics is typical for calibrators and controls used in clinical chemistry, as their primary function is to ensure the accuracy and reliability of the analytical methods themselves, rather than directly analyzing patient images or data using advanced algorithms.
N/A
Intended Use / Indications for Use
C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. 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 present 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 (comma separated list FDA assigned to the subject device)
JIX, JJY
Device Description
Device 1 (C.f.a.s. PUC): C.f.a.s. PAC is a liquid, ready-for-use calibrator consisting of a buffered aqueous solution with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in the product labeling.
Device 2 (Precinorm ® PUC/ Precipath ® PUC): 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. Values for constituent analytes are provided in the product labeling.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JAN 3 1 2005
510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) PUC (Proteins in Urine/CSF); Precinorm ® PUC and Precipath ® 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: January 5, 2005 |
| Device 1 Name | Proprietary name: Roche Diagnostics C.f.a.s. (Calibrator for automated
systems) PUC (Proteins in Urine/CSF) |
| | Common name: C.f.a.s. PUC |
| | Classification name: Calibrator, multi-analyte mixture |
| Device 2 Name | Proprietary name: Roche Diagnostics Precinorm® PUC (Proteins in
Urine/CSF) and Precipath® PUC (Proteins in Urine/CSF |
| | Common name: Precinorm® PUC / Precipath® PUC |
| | Classification name: Multi-analyte controls, all kinds (assayed and
unassayed) |
| | |
Continued on next page
1
:
| Device 1
description | C.f.a.s. PAC is a liquid, ready-for-use calibrator consisting of a buffered
aqueous solution with biological materials added as required to obtain desired
component levels. Values for constituent analytes are provided in the product
labeling. |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device 2
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. Values for
constituent analytes are provided in the product labeling. |
| Device 1
Intended use | C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on
Roche clinical chemistry analyzers as specified in the enclosed value sheet. |
| Device 2
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 |
| Device 1
Substantial
Equivalence | For C.f.a.s. PUC, Roche claims substantial equivalence to the currently
marketed currently marketed C.f.a.s. PUC, K040264. |
| Substantial
equivalence
comparison -
Device 1 | The table below compares C.f.a.s. PUC with its predicate device (currently
marketed C.f.a.s. PUC, K040264). |
| | Continued on next page |
2
| Characteristic | C.f.a.s. PUC (Predicate device, K040264) | C.f.a.s. PUC (Modified Device) |
|---|---|---|
| Intended Use | C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. | Same |
| Format | Liquid ready-for-use calibrator based on a buffered aqueous solution. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. | Same |
| Stability | Unopened | |
| Stable at 2-8°C until expiration date | ||
| Opened: | ||
| Stable at 2 to 8°C for 4 weeks | Same | |
| Level | Single level | Same |
| Constituent | ||
| Analytes with | ||
| Assigned | ||
| Values | • Albumin | |
| • Total protein | • Albumin | |
| • Total protein | ||
| • Immunoglobulin G | ||
| Device 2 For Precinorm ® PUC and Precipath ® PUC, Roche claims substantial |
| Substantial
Equivalence | For Precinorm ® PUC and Precipath ® PUC, Roche claims substantial
equivalence to the currently marketed Roche Diagnostics Precinorm ® PUC
and Precipath ® PUC (K041812). |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence -
Device
comparison | The table below compares Precinorm ® PUC / Precipath® PUC with the
predicate device (currently marketed Precinorm ® PUC / Precipath® PUC). |
Continued on next page
,
: 上一篇:
3
| Characteristic | Precinorm ® PUC / Precipath®
PUC (Predicate device, K040264) | Precinorm ® PUC /
Precipath® PUC (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 | Precinorm |
| | • Albumin
• Creatinine
• Total Protein | • Albumin
• Creatinine
• Total Protein
• Immunoglobulin G |
| | Precipath | Precipath |
| | • Albumin
• Creatinine
• Total Protein
• Immunoglobulin A
• Immunoglobulin M | • Albumin
• Creatinine
• Total Protein
• Immunoglobulin A
• Immunoglobulin M
• Immunoglobulin G |
4
| Characteristic | Precinorm ® PUC / Precipath®
PUC (Predicate device, K040264) | Precinorm ® PUC /
Precipath® PUC (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
• Immunoglobulin A
• Immunoglobulin M | Precinorm
• Albumin
• Creatinine
• Total Protein
• Immunoglobulin G
Precipath
• Albumin
• Creatinine
• Total Protein
• Immunoglobulin A
• Immunoglobulin M
• Immunoglobulin G |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, PhD, RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250
K050026 Re:
K050020
Trade/Device Name: C.f.a.s (Calibrator for Automated Systems) Proteins in Urine/CSF (PUC) Precinorm® Proteins in Urine/CSF (PUC) and Precipath ® PUC
JAN 3 1 2005
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: January 5, 2005 Received: January 6, 2005
Dear Dr. Ambrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Soctor 9 rotty premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobars) to 16garry the enactment date of the Medical Device Amendments, or to conninered price to May 20, 1970, the ecordance with the provisions of the Federal Food, DINA de vices that have occh roomsonied in assee approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The I ou may, arere, mains 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 n may or bable of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of acress 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 or any 1 vith 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).
6
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to obgin manically your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarked notification: "The PDA Intentig of casification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements o your device, of fu If you desire specific information acour are app a martice, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the Ville Dagliostic Device Device and reason to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the 1 ou may ovant other general meritational 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,
Sean 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
7
Indications for Use
K050026 510(k) Number (if known): -
Device Name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® 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 present 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)
Division Sign-Off
Office of In Vitro Diagnosiic Device Evaluation and St
510(k) K07026
Page 1 of
8
Indications for Use
510(k) Number (if known):
Device Name:_C.f.a.s. (Calibrator for Automated Systems) Proteins in Urine/CSF (PUC)
Indications For Use:
C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
cting
Division Sign-Off
e of In Vitro Diagnostic vice Evaluation and Safety Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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