COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226

Q: Who is the manufacturer of COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226?

Roche Diagnostics Corp. filed the 510(k) submission for COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 (K063543).

Q: What is the FDA product code for COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226?

CIG. It is classified under 21 CFR 862.1110 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226?

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

Q: What are the predicate devices for COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226?

COBAS INTEGRA Bilirubin Direct (k951595); COBAS INTEGRA Total Bilirubin Special (k981632); Roche/Hitachi Bilirubin Total (k981632).

Q: Who can help prepare an FDA 510(k) submission like COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226?

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.

K063543 · Roche Diagnostics Corp. · CIG · Dec 22, 2006 · Clinical Chemistry

Device Facts

Record ID	K063543
Device Name	COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
Applicant	Roche Diagnostics Corp.
Product Code	CIG · Clinical Chemistry
Decision Date	Dec 22, 2006
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1110
Device Class	Class 2
Attributes	Pediatric

Intended Use

COBAS INTEGRA Bilirubin Direct: The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049). COBAS INTEGRA Total Bilirubin Special: The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates (test BILTS, 0-985). Roche Hitachi Total Bilirubin Special: For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers. Measurement of the levels of bilirubin and organic compound formed during the normal and abnormal distruction of red cells, if used in the diagnosis of liver, hemolytic hemoatological, and metabolic disorders, including hepatitis and gall bladder block

Device Story

In vitro diagnostic reagent systems for quantitative bilirubin measurement in serum/plasma; used on COBAS INTEGRA and Roche/Hitachi automated clinical chemistry analyzers. Principle of operation: Diazo method. Modifications include updated traceability to Doumas reference method, revised reagent pH, updated lower detection limits, and refined interference specifications (lipemia/hemolysis). Operated by laboratory technicians in clinical settings. Output is quantitative bilirubin concentration; used by clinicians to diagnose liver, hemolytic, hematological, and metabolic disorders. Benefits include standardized, accurate bilirubin monitoring for adults and neonates.

Clinical Evidence

Bench testing only. Performance verified through interference testing, sensitivity analysis (lower detection limit), and validation of reagent modifications against predetermined acceptance criteria.

Technological Characteristics

In vitro diagnostic reagents; Diazo method. Reagent composition includes sodium acetate buffer, sulfamic acid, hydrochloric acid, and diazonium ion. Automated analysis on COBAS INTEGRA and Roche/Hitachi systems. Traceability to Doumas reference method. Software-controlled automated clinical chemistry analyzer platform.

Indications for Use

Indicated for the quantitative determination of bilirubin in human serum and plasma.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

COBAS INTEGRA Bilirubin Direct (k951595)
COBAS INTEGRA Total Bilirubin Special (k981632)
Roche/Hitachi Bilirubin Total (k981632)

Related Devices

K081193 — COBAS INTEGRA 400/800 BILIRUBIN TOTAL · Roche Diagnostics · Jan 16, 2009
K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 · Elitechgroup · Jul 11, 2017
K981883 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 · Boehringer Mannheim Corp. · Jul 7, 1998
K123965 — COBAS INTEGRA BILIRUBIN DIRECT GEN.2 · Roche Diagnostics · Feb 28, 2013
K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR · Stanbio Laboratory · Jun 30, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary K063543 Roche Diagnostics Corporation hereby submits this Bundled Special 510(k): Introduction Device Modification to provide notification of modifications to our Bilirubin (Total and Direct) test systems. The reagents were originally cleared for use as: > COBAS INTEGRA Bilirubin Direct K951595 COBAS INTEGRA Total Bilirubin Special K981632/A001 Roche/Hitachi Total Bilirubin K981632/A001 Note that COBAS INTEGRA Total Bilirubin Special and Roche/Hitachi Total Bilirubin are different applications of the exact same reagent. Modifications to the test systems include: Device 1: COBAS INTEGRA Bilirubin Direct - Changes to the traceability . - In the Limitations section, quantification of lipemia and hemolysis . interference, rather than a statement to avoid lipemia and hemolyzed specimens - Clarification for reagent handling . - Change to pH value for R1 from 1.1 to 1.2 . - Change in stated lower detection limit from 0.81 umol/L to 1.7 . umol/L. The change is due to Roche's decision to redefine the lower detection limit for clinical chemistry test systems to match the lower end of the measuring range even if data support a lower detection limit. This does not represent a change in actual performance; but rather only a change in the stated performance claim. - Change in recommended calibrator to the Calibrator for Automated . systems (C.f.a.s.) cleared by FDA under 510(k) K062319 - Other editorial labeling changes . Device 2: COBAS INTEGRA Total Bilirubin Special K981632/A001 - . Modifications to specimen collection - Labeling changes addition of two clarifying statements in the . Specimen collection and preparation section: "Do not use cordblood samples" and "Underfilled lithium heparin sample tubes may cause elevated results" - Other editorial labeling changes . Continued on next page {1}------------------------------------------------ # 510(k) Summary – Calibrator for Automated Systems (C.f.a.s), Continued | Introduction (continued) | Device 3: Roche/Hitachi Total Bilirubin K981632/A001 | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Modifications to specimen collection section to include clarification that underfilled lithium heparin sample tubes may cause elevated results Clarification for reagent handling Labeling changes – Addition of two clarifying statements in the Specimen collection and preparation section: “Do not use cordblood samples” and “Underfilled lithium heparin sample tubes may cause elevated results” Other editorial labeling changes | | Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-3723 Contact person: Corina Harper Date prepared: October 30, 2006 | | Device Name | Device 1: Proprietary name: COBAS INTEGRA Bilirubin Direct Common name: Bilirubin Direct Classification name: Bilirubin (total or direct) test system Device 2: Proprietary name: COBAS INTEGRA Total Bilirubin Special Common name: Total Bilirubin Classification name: Bilirubin (total or direct) test system Device 3: Proprietary name: Roche/Hitachi Total Bilirubin Common name: Total Bilirubin Classification name: Bilirubin (total or direct) test system | {2}------------------------------------------------ The establishment registration number for Roche Diagnostics Gmbh Penzberg Establishment registration is 9610529. > The establishment registration number for Roche Diagnostics Corporation Indianapolis is 1823260. | Classification | The FDA has classified Bilirubin (total or direct) test system in Class II. | | | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------|------------------------| | | Panel | Classification Number | Classification Name | Regulation Citation | | | 75 Clinical Chemistry | CIG | Bilirubin (total or direct) test system | 21 CFR 862.1110 | | Device Description | The COBAS INTEGRA and Roche/Hitachi total or direct reagent is intended for use on the COBAS INTEGRA and Roche/Hitachi systems for the quantitative determination of total or direct bilirubin in serum and plasma. | | | | | Intended use | Device 1: COBAS INTEGRA Bilirubin Direct: The cassette COBAS INTERGA Bilirubin Direct contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma.. Device 2: COBAS INTEGRA Total Bilirubin Special: The COBAS INTERGA Total Bilirubin Special cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. Device 3: Roche/Hitachi Total Bilirubin: For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers. | | | | | Predicate Device | We claim substantial equivalence to Device 1: Bilirubin Direct cleared as K951595 Device 2: Total Bilirubin cleared as K981632/A001 Device 3: Total Bilirubin cleared as K981632/A001 | | | | Continued on next page {3}------------------------------------------------ ## 510(k) Summary – Calibrator for Automated Systems (C.f.a.s), Continued ______________________________________________________________________________________________________________________________________________________________________________ The table below indicates the similarities and differences between the Substantial equivalency modified Bilirubin direct or total reagents and their predicate devices. Similarities | Feature | Predicate device: | Modified device: | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | | Device 1: COBAS INTEGRA Bilirubin Direct K951595 | COBAS INTEGRA Bilirubin Direct | | | Device 2: COBAS INTEGRA Total Bilirubin Special K981632/A001 | COBAS INTEGRA Total Bilirubin Special | | | Device 3: Roche/Hitachi Total Bilirubin K981632/A001 | Roche/Hitachi Total Bilirubin | | General | | | | Intended Use/ Indications for Use | Device 1: COBAS INTEGRA Bilirubin Direct The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049). | Same | | | Device 3: COBAS INTEGRA Total Bilirubin Special The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates (test BILTS, 0-985). | Same | | | Roche Hitachi Total Bilirubin Special For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers. | Same | | Specimen | Device 1: serum and plasma | Same | | | Device 2: serum and plasma of adults and neonates | Same | | | Device 3: serum and plasma of adults and neonates | Same | | Test Principle | | | | Reference method | Device 1: Diazo method | Same | | | Device 2: Diazo method | Same | | | Device 3: Diazo method | Same | | Reagent information | | | | Reagent composition | Device 2: COBAS INTEGRA Total Bilirubin Special R1: Sodium acetate buffer 85 mmol/L, Sulfamic acid 110 mmol/L R2: Hydrochloric acid 100 mmol/L, Diazonium ion 3 mmol/L | Same | | | Device 3: Roche/Hitachi Total Bilirubin R1: Sodium acetate buffer 85 mmol/L, Sulfamic acid 110 mmol/L R2: Hydrochloric acid 100 mmol/L, Diazonium ion 3 mmol/L | Same | | Stability - shelf life and on- board | Device 1: 15-25 °C until expiration date On-board at 8 °C 12 weeks | 15-25 °C until expiration date COBAS INTEGRA 400/400 plus: On-board at 10-15 °C 8 weeks COBAS INTEGRA 700/800: On-board at 8 °C 12 weeks | | | Device 2: 2-8 °C until expiration date COBAS INTEGRA 700 On-board at 8 °C 5 weeks | 2-8 °C until expiration date COBAS INTEGRA 400/400 plus: On-board at 10-15 °C 5 weeks COBAS INTEGRA 700/800: On-board at 8 °C 5 weeks | | | Device 3: 2-8 °C until expiration date 35 days opened and refrigerated on the analyzer | Same | | | | | | Calibrator | Device1: Calibrator (human) | Calibrator f.a.s. | | | Device 2: Calibrator f.a.s. | Same | | | Device 3: Calibrator f.a.s. | Same | | Quality control | Device1: Control Serum N Control Serum P | Precinorm U, Precipath U Precinorm U plus, Precipath U plus, | | | Device 2: Precinorm U, Precipath U Precinorm U plus, Precipath U plus | Same | | | Device 3: Precinorm U, Precipath U Precitrol N, Precitrol A, | Precinorm U, Precipath U Precinorm U plus, Precipath U plus | | Traceability | Device 2: Standardized against the Doumas reference method | Same | | | Device 3: Standardized against the Doumas reference method | Same | | Performance characteristics | | | | | | | | Precision | Device1: Within run: 1.7% @ 6.1 µmol/L 0.53% @ 20.1 µmol/L Between day: 1.1% @ 6.1 µmol/L 1.1% @ 20.1 µmol/L Total: 1.9% @ 6.1 µmol/L 1.2% @ 20.1 µmol/L | Same Within run and total CV% reported | | | Device 2: Within run: 2.44% @ 15.80 µmol/L 1.39% @ 54.00 µmol/L Between day: 4.13% @ 14.7 µmol/L 2.15% @ 47.20 µmol/L | Same | | | Device 3: Within run: 0.4% @ 18.53 mg/dL 2.8% @ 0.91mg/dL Between day: 2.5% @ 18.08 mg/dL 4.9% @ 0.89 mg/dL | Within run: 0.81% @ 18.81 mg/dL 3.1% @ 0.87 mg/dL Between day: 0.83% @ 15.41 mg/dL 2.2% @ 0.86 mg/dL | | Measuring range | Device1: 0-20 mg/dL | 0.10-25 mg/dL | | | Device 2: 0-25 mg/dL 0-250 mg/dL (with postdulion) | 0-25 mg/dL 0-100 mg/dL (with postdulion) | | | Device 3: 0.1-35.0 mg/dL | Same | | Lower | Device1: | | | | | | | detection limit | 3.1 x 10-3 $ΛA$ per mg/dL of direct | 0.10 mg/dL | | | bilirubin | | | | | | | | Device 2: | | | | 0.063 mg/dL | Same | | | | | | | Device 3: | | | | 0.1 mg/dL | Same | | | | | | Expected | Device1: | | | values | Serum 0-0.2 mg/dL | Same | | (literature | | | | reference) | | | | | Device 2 and 3: | Same for Device 2 and 3 | | | Adults and children: up to 1.0 | | | | mg/dL | | | | | | | | Neonates: | | | | | | | | Age of newborn Premature | | | | 24hrs: 1.0-6.0 mg/dL | | | | 48hrs: 6.0-8.0 mg/dL | | | | 3-5 days: 10.0-15.0 mg/dL | | | | | | | | Age of newborn Full Term | | | | 24hrs: 2.0-6.0 mg/dL | | | | 48hrs: 6.0-7.0 mg/dL | | | | 3-5 days: 4.0-12.0 mg/dL | | | | | | | Endogenous | Device 3: | | | interferences | Serum and Plasma: | Same | | | Hemolysis: no significant | | | | interferences up to an H index of | | | | 1000 | | | | Lipemia: | | | | significant negative | N/A - assay not offered on this | | | interferences at an L index | instruments | | | | | | | greater than 600 (on Hitachi | | | | 704,717,914,736,737,747) | | | | No significant interference up | Same | | | to an L index of 1000 (on | | | | Hitachi 902,911, 912, 917) | | | | | | | Exogenous | Device 2: | Same | | interferences | Ascorbic acid at 30 mg/dL causes | | | | artificially decreased total bilirubin | | | | values | | | | | | | | Device 3: | Same | | | Indican: no significant interferences | | | | up to levels of 10 mg/dL | | {4}------------------------------------------------ . : {5}------------------------------------------------ . : . : {6}------------------------------------------------ : {7}------------------------------------------------ : : {8}------------------------------------------------ ## 510(k) Summary – Calibrator for Automated Systems ## (C.f.a.s), Continued | Substantial | The table below indicates the differences between the modified Bilirubin | |-------------|--------------------------------------------------------------------------| | Differences | direct or total reagents and their predicate devices. | | Feature | Predicate device: COBAS INTEGRA Bilirubin Direct K951595 | Modified device: COBAS INTEGRA Bilirubin Direct | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | | COBAS INTEGRA Total Bilirubin Special K981632/A001 | COBAS INTEGRA Total Bilirubin Special | | | Roche/Hitachi Total Bilirubin K981632/A001 | Roche/Hitachi Total Bilirubin | | Reagent information | | | | Reagent composition | Device 1: COBAS INTEGRA Bilirubin Direct R1: Sulfanic acid 35 mmol/L, Oxalic acid 40 mmol/L, HEDTA 4.0 mmol/L, pH 1.1 | R1: Sulfanic acid 35 mmol/L, Oxalic acid 40 mmol/L, HEDTA 4.0 mmol/L, pH 1.2 | | | R2: Sodium nitrite 3.9 mmol/L, pH 6.0 | Same | | Traceability | Device 1: Standardized against the manual test performance using the Jendrassic Grof method | Standardized against the Doumas reference method | | Endogenous interferences | Device1: Hemolysis: even slight hemolysis interferes with the test Lipemia: : even slight lipemia interferes with the test | Hemolysis: No significant interference up to an H index of 10 Lipemia: No significant interference up to an L index of 270 | | | Device 2: Hemolysis: No significant interference up to 1000 mg/dL Lipemia: No significant interference up to 1800 mg/dL as Intralipid | Hemolysis: No significant interference up to 1000 mg/dL Lipemia: No significant interference up to 1400 mg/dL as Intralipid | {9}------------------------------------------------ | Additional information for modifications to values assignment process and traceability | Direct Bilirubin: Roche Diagnostics has revised the calibration of the COBAS INTEGRA Bilirubin Direct method due to ongoing quality assurance and customer feedback. Traceability was changed to the Doumas method, and the concurrent change in Quality Control limits for this method were intended to minimize or eliminate any discrepancies seen by the users. The impact of using new setpoints was shift to direct bilirubin values lower when compared to the values obtained using previous setpoints. The shift occurred in both controls and patient specimens. The revised setpoints or revised values for controls and its clinical significance were communicated to the customers via Reagent Bulletins in April 2002, March 2004, November 2004. Another communication regarding low recovery of Precinom U/Precinorm U Plus controls was communicated in May 2006. | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Total Bilirubin: Roche Diagnostics has re-evaluated the assignments for the Total Bilirubin assays and has adjusted the C.f.a.s calibrator setpoints for both methods available on the COBAS INTEGRA and Roche/Hitachi analyzers. This change was triggered by internal investigation and customer feedback. The Roche Diagnostics US Standardization laboratory has reassigned the values based on a new procedure which maintained the same traceability to the Doumas method. The results were verified by using US reference laboratory. The revised setpoints or revised values for controls were communicated to the customers via a Reagent Bulletins in August 2006. | | Proposed Labeling | Proposed labeling sufficient to describe the device, its intended use, and the directions for use can be found in Section V. We believe the proposed version of the device labeling presented contains all of the technical information required per 21 CFR 809.10. | | Validation and Design Control | Development activities were conducted under appropriate design control procedures and the overall product specifications were met. The Declaration of Conformity with Design Controls and Results of Risk Analysis are provided in Section 5.1. Analytical Performance. | | Confidentiality | Roche Diagnostics Corporation requests that the FDA not disclose the nature or existence of this submission until the substantial equivalence decision has been reached. | {10}------------------------------------------------ Modification of the Bilirubin Direct and Total reagents does not affect the Closing intended use or indications for use of the device as described in the labeling, nor does it alter the fundamental scientific technology of the device. Therefore, we trust the information provided in this Special 510(k) will support a decision of substantial equivalence of the Bilirubin Direct and Total to their predicate. > If you have any questions or require further information, please do not hesitate to contact this office. - Phone: (317) 521-3831 - · FAX: (317) 521-2324 - email: corina.harper@roche.com {11}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Corina Harper, Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 DEC 2 2 2006 Re: k063543 > Trade/Device Name: COBAS Integra Bilirubin Direct COBAS Integra Total Bilirubin Special Roche/Hitachi Bilirubin Total Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: November 22, 2006 Received: November 24, 2006 Dear Ms. Harper: 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). {12}------------------------------------------------ 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Jean M. Cooper, M.S., D.V.M. Sean M. Cooper, M.S., 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 {13}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known): K063543 Device Name: ### COBAS INTEGRA Bilirubin Direct COBAS INTEGRA Total Bilirubin Special Roche/Hitachi Total Bilirubin #### Indications For Use: COBAS INTEGRA Bilirubin Direct The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049). #### COBAS INTEGRA Total Bilirubin Special The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates (test BILTS, 0-985). Roche Hitachi Total Bilirubin Special For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers. Measurement of the levels of bilirubin and organic compound formed during the normal and abnormal distruction of red cells, if used in the diagnosis of liver, hemolytic hemoatological, and metabolic disorders, including hepatitis and gall bladder block Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrenge of ODRH, Office of In Vitro Diagnostic Devices (OIVD) Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1

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COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226

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