Who is the manufacturer of ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

Roche Diagnostics filed the 510(k) submission for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260).

What is the FDA product code for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

DDR. It is classified under 21 CFR 866.5680 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

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

Who can help prepare an FDA 510(k) submission like ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

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.

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

Q: What are the predicate devices for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

Elecsys Myoglobin STAT assay (K983176).

K083260 · Roche Diagnostics · DDR · Oct 16, 2009 · Immunology

Device Facts

Record ID	K083260
Device Name	ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
Applicant	Roche Diagnostics
Product Code	DDR · Immunology
Decision Date	Oct 16, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5680
Device Class	Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys Myoglobin and Myoglobin STAT assays are in vitro diagnostic tests for quantitative myoglobin measurement in human serum and plasma. The device utilizes a two-step sandwich immunoassay principle with two monoclonal antibodies against human myoglobin, streptavidin-coated microparticles, and electrochemiluminescence (ECLIA) detection. The system operates on Elecsys and cobas e immunoassay analyzers. Input samples are processed via automated incubation (18 minutes for standard, 9 minutes for STAT) and signal detection. Results are calculated using a master curve provided via reagent barcode and instrument-specific 2-point calibration. The output is a quantitative myoglobin concentration (ng/mL), which clinicians use to aid in the rapid diagnosis of heart and renal disease. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluated via precision (repeatability and intermediate precision) and method comparison studies. Method comparison (N=129 for Myoglobin, N=139 for Myoglobin STAT) against predicate showed high correlation (r=0.999 for Myoglobin; r=0.997 for Myoglobin STAT via Deming regression). Measuring range established at 21-3000 ng/mL. Interference testing confirmed no significant effect from hemolysis, biotin, lipemia, bilirubin, or rheumatoid factor.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin microparticles; monoclonal antibodies. Analyzers: Elecsys and cobas e series. Measuring range: 21-3000 ng/mL. Calibration: 2-point calibration with master curve via reagent barcode. Connectivity: Integrated with Elecsys/cobas e analyzer software.

Indications for Use

Indicated for in vitro quantitative determination of myoglobin in human serum and plasma to aid in rapid diagnosis of heart and renal disease. For use on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

Elecsys Myoglobin STAT assay (K983176)

Related Devices

K983176 — ELECSYS MYOGLOBIN STAT ASSAY · Boehringer Mannheim Corp. · Sep 24, 1998
K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB · Roche Diagnostics Corp. · Aug 29, 2002
K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS · Ortho-Clinical Diagnostics, Inc. · Nov 5, 2003
K991796 — IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 · Diagnostic Products Corp. · Jun 9, 1999
K983848 — ABBOTT AXSYM MYOGLOBIN · Abbott Laboratories · Nov 16, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ # 11083260 OCT 1 6 2009 # 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction 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 - 3225 | | | |----------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|--| | | Contact person: | Jack Rogers, Regulatory Affairs Principal | | | | Date prepared: | September 30, 2009 | | | Device Name | Proprietary name: | 1) Elecsys Myoglobin Immunoassay 2) Elecsys Myoglobin STAT Immunoassay | | | | Common name: | 1) Myoglobin Immunoassay 2) Myoglobin STAT Immunoassay | | | | Classification name: | Myoglobin immunological test system | | | Classification | 21 CFR 866.5680; Class 2 | | | | Device | The Elecsys Myoglobin Immunoassay includes two applications of the same | | | reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Page 1 of 6 Description Image /page/0/Picture/7 description: The image shows the word "Roche" inside of a hexagon. The word is written in a bold, sans-serif font. The hexagon is outlined in black. The image is simple and clear, with a focus on the company name. {1}------------------------------------------------ Intended Use / Indications for Use #### Elecsys Myoglobin Immunoassay Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. #### Elecsys Myoglobin STAT Immunoassay Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. The Elecsys Myoglobin and Elecsys Myoglobin STAT assays are Predicate substantially equivalent to the Elecsys Myoglobin STAT assay (K.983176). Device Substantial Equivalence -Device Comparison The following table compares the new Elecsys Myoglobin and Elecsys Myoglobin STAT assays with the predicate device Elecsys Myoglobin STAT Assay (K983176). | Feature | Elecsys Myoglobin and Myoglobin STAT | Elecsys Myoglobin STAT (K983176) Predicate | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for Use | Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. | Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. | | Assay Protocol | Electrochemiluminescence immunoassay | Electrochemiluminescence immunoassay | | Specimen Type | Human serum and plasma | Human serum and plasma | Image /page/1/Picture/12 description: The image shows the logo for Roche, a healthcare company. The logo consists of the word "Roche" written in a bold, sans-serif font. The word is enclosed within a hexagon shape. The hexagon is outlined in black. {2}------------------------------------------------ | Feature | Elecsys Myoglobin and Myoglobin STAT | Elecsys Myoglobin STAT (K983176) Predicate | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Measuring Range | 21-3000 ng/ml. defined by the lower detection limit and the maximum of the master curve). Values below the detection limit are reported as <21 ng/ml. Values above the measuring range are reported as >3000 ng/mL (or up to 3000 ng/mL for 10-fold diluted samples) | 15-3000 ng/mL (defined by the lower detection limit and the maximum of the master curve). Values below the detection limit are reported as <15 ng/ml. Values above the measuring range are reported as ≥ 3000 ng/mL (or up to 3000 ng/mL for 10-fold diluted samples) | | Expected values | Men 28-72 ng/ml Women 25-58 ng/ml Based on a study with Elecsys Myoglobin STAT assay | Men < 72 ng/ml Women < 51 ng/ml Based on a study with Tina-quant Myoglobin. | | Traceability / Standardization | Myoglobin assay The Elecsys Myoglobin assay has been standardized against the Elecsys Myoglobin STAT assay. Myoglobin STAT assay This method has been standardized against an in-house reference preparation. | Calibrated against Tina-quant Myoglobin which was calibrated against a nephelometric method. | | Dilution | Recommended dilution factor is 1:10. The concentration of the diluted sample must be >50 ng/ml. | Recommended dilution factor is 1:10. The concentration of the diluted sample must be >200 ng/mL. | ・ . ## Substantial Equivalence – Device Comparison (continued) Roche ・ {3}------------------------------------------------ | Feature | Elecsys Myoglobin and Myoglobin STAT | Elecsys Myoglobin STAT (K983176) Predicate | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Characteristics | | | | Precision | Myoglobin assay Repeatability (within run) 2.0% CV @ 32.0 ng/mL 1.0% CV @ 87.0 ng/mL 1.8% CV @ 1020 ng/mL 1.1% CV @ 1194 ng/mL 1.8% CV @ 2474 ng/mL | Repeatability (within run) 2.1% CV @ 43.0 ng/mL 1.3% CV @ 82.5 ng/mL 2.9% CV @ 237 ng/mL 2.9% CV @ 523 ng/mL 1.9% CV @ 672 ng/mL 3.4% CV @ 1147 ng/mL 5.3% CV @ 3056 ng/mL | | | Intermediate Precision (Total) 2.3% CV @ 32.0 ng/mL 1.5% CV @ 87.0 ng/mL 2.5% CV @ 1020 ng/mL 1.8% CV @ 1194 ng/mL 2.2% CV @ 2474 ng/mL | Intermediate Precision (Total) 2.6% CV @ 43.0 ng/mL 1.6% CV @ 82.5 ng/mL 3.6% CV @ 237 ng/mL 3.8% CV @ 523 ng/mL 2.3% CV @ 672 ng/mL 4.0% CV @ 1147 ng/mL 6.7% CV @ 3056 ng/mL | | | Myoglobin STAT assay Repeatability (within run) 1.7% CV @ 33.9 ng/mL 1.2% CV @ 90.1 ng/mL 1.8% CV @ 1016 ng/mL 1.1% CV @ 1171 ng/mL 2.2% CV @ 2468 ng/mL Intermediate Precision (Total) 2.1% CV @ 33.9 ng/mL 1.3% CV @ 90.1 ng/mL 2.2% CV @ 1016 ng/mL 1.3% CV @ 1171 ng/mL 2.6% CV @ 2468 ng/mL | | | Feature | Elecsys Myoglobin and Myoglobin STAT | Elecsys Myoglobin STAT (K983176) Predicate | | | Performance Characteristics (continued) | | | Method Comparison | Myoglobin assay N = 129 Range: 24 to 2945 Passing/Bablok Slope = 1.03 Intercept = 6.26 r = 0.987 Linear Regression Slope = 1.02 Intercept = 14.5 r = 0.999 Deming Regression Slope = 1.00 Intercept = 13.9 r = 0.999 Myoglobin STAT assay N = 139 Range: 23 to 2523 Passing/Bablok Slope = 1.04 Intercept = -2.08 r = 0.955 Linear Regression Slope = 1.08 Intercept = -9.60 r = 0.988 Deming Regression Slope = 1.09 Intercept = -14.6 r = 0.997 | N = 398 Range: 26 to 595 Passing/Bablok Slope = 1.01 Intercept = -0.135 r = 0.996 Linear Regression Slope = 0.997 Intercept = 1.284 r = 0.996 | | Limit of Blank | 18 ng/mL | Not Reported | | Limit of Detection | 21 ng/mL | 21 ng/mL | | Limit of Quantitation | 25 ng/mL | Not Reported | | Feature | Elecsys Myoglobin and Myoglobin STAT | Elecsys Myoglobin STAT (K983176) Predicate | | | Performance Characteristics (continued) | | | Interferences (limitations) | Hemolytic no effect up to 1.4 g/dL Biotin no effect up to 50 ng/mL Lipemia no effect up to 2200 mg/dL Bilirubin no effect up to 65 mg/dL Rheumatoid factor no effect up to 1500 IU/mL | Same | #### Substantial Equivalence – Device Comparison (continued) Image /page/3/Picture/3 description: The image shows the word "Roche" inside of a hexagon. The word is written in a simple, sans-serif font. The hexagon is outlined in black and appears to be a logo for the company Roche. : . {4}------------------------------------------------ #### Substantial Equivalence – Device Comparison (continued) Image /page/4/Picture/3 description: The image shows the Roche logo. The logo consists of the word "Roche" written in black letters inside of a hexagon. The hexagon is also black and has a thick border. . {5}------------------------------------------------ . r . : : : : #### Substantial Equivalence - Device Comparison (continued) , Image /page/5/Picture/5 description: The image shows the Roche company logo. The logo consists of the word "Roche" in bold, sans-serif font, enclosed within a hexagon. The hexagon is outlined in black. : 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved shapes. Roche Diagnostics Centralized Diagnostics c/o Mr. Jack Rogers Regulatory Affairs Principal RPD Regulatory Submissions 9115 Hague Road Indianapolis, IN 46250 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 # OCT 1 6 2009 Re: k083260 > Trade Name: Elecsys® Myoglobin Immunoassay, Elecsys® Myoglobin STAT Immunoassay Regulation Number: 21 CFR §866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Codes: DDR Dated: September 30, 2009 Received: October 1, 2009 Dear Mr. Rogers: 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {7}------------------------------------------------ Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, CA Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### Indications for Use 510(k) Number: K083260 Device Name: Elecsys Myoglobin Immunoassay Indications For Use: Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. Prescription Use X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) |4083260 Page 1 of 2 {9}------------------------------------------------ ### Indications for Use 510(k) Number: K083260 Device Name: Elecsys Myoglobin STAT Immunoassay Indications For Use: - Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) Signature Division Sign-Off Affice of In Vitro Diagnostic Device Evaluation and Safety 510(k) 16083260 Page 2 of 2