Who is the manufacturer of PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

Roche Diagnostics filed the 510(k) submission for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC (K050026).

What is the FDA product code for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

JIX. It is classified under 21 CFR 862.1150 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC

K050026 · Roche Diagnostics · JIX · Jan 31, 2005 · Clinical Chemistry

Device Facts

Record ID	K050026
Device Name	PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
Applicant	Roche Diagnostics
Product Code	JIX · Clinical Chemistry
Decision Date	Jan 31, 2005
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1150
Device Class	Class 2

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. 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 ® 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.

Device Story

Modified Precipath/Precinorm Proteins in Urine control and C.f.a.s. PUC calibrator; modification involves addition of Immunoglobulin G (IgG) constituent to existing formulations. Device used in clinical laboratory settings to monitor assay performance and calibrate protein measurements in urine. Modification verified via risk analysis (FMEA) and design control activities to ensure fundamental scientific technology remains unchanged. Output consists of standardized control/calibration values for clinical chemistry analyzers.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

In vitro diagnostic control and calibrator materials. Modification consists of adding Immunoglobulin G (IgG) to existing liquid/lyophilized formulations. Fundamental scientific technology remains consistent with previously cleared predicates. Compliance with 21 CFR 820.30 design controls.

Indications for Use

Indicated for use as a calibrator (C.f.a.s. PUC) or quality control material (Precinorm/Precipath PUC) for quantitative Roche clinical chemistry methods measuring proteins in urine or cerebrospinal fluid (CSF).

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

Related Devices

K040264 — CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF · Roche Diagnostics Corp. · Apr 2, 2004
K041812 — MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) · Roche Diagnostics Corp. · Jul 27, 2004
K040280 — PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS · Roche Diagnostics Corp. · Mar 11, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ K050026 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): K050026 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 ____________________________________________________________________________________________________________________________________________________________________ 24