(30 days)
No
The description focuses on standard photometric and turbidimetric analysis methods and does not mention any AI/ML components or capabilities.
No.
Explanation: The device is an in-vitro diagnostic system used for quantitative determination of bilirubin in human samples, which aids in diagnosis of various disorders. It performs analytical measurements on biological samples outside the body and does not directly treat or prevent a disease in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements are "used in the diagnosis of liver, hemolytic hematological and metabolic disorders." Additionally, the "Device Description" states that the cobas c 111 analyzer is a "partially automated, in-vitro diagnostic analyzer."
No
The device description clearly states it is a reagent intended for use on a physical analyzer (cobas c 111 system), which is a hardware device. The 510(k) is for the reagent, not the software controlling the analyzer.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "In vitro test for the quantitative determination of total bilirubin in human serum and plasma". This clearly indicates it is used to test samples taken from the human body outside of the body.
- Device Description: The device description refers to the "Total Bilirubin Special reagent" and the "cobas c 111 analyzer" as being used for "in-vitro diagnostic analyzer".
- Purpose: The purpose of measuring bilirubin levels is for the "diagnosis of liver, hemolytic hematological and metabolic disorders". This is a diagnostic purpose.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system. Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.
Product codes (comma separated list FDA assigned to the subject device)
CIG
Device Description
The Total Bilirubin Special reagent is intended for use on the cobas c 111 analyzer for the quantitative determination of total or direct bilirubin in serum and plasma. The cobas c 111 analyzer is a partially automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. The cobas c 111 instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an optional ion selective electrodes (ISE).
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
professional environment
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)
Comparison of performance characteristics between the modified device (Total Bilirubin Special on cobas c 111) and the predicate device (COBAS INTEGRA Total Bilirubin Special, K063543).
Precision:
Modified Device:
Within-run: 1.79% @ 21.7 µmol/L, 0.64% @ 64.2 µmol/L, 2.94% @ 15.2 µmol/L, 0.77% @ 60.0 µmol/L
Total: 2.32% @ 21.6 µmol/L, 0.71% @ 67.4 µmol/L, 3.10% @ 16.2 µmol/L, 0.79% @ 83.0 µmol/L
Predicate device:
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
Measuring Range:
Modified Device: 0.1-25.2 mg/dL without postdilution; 0.1-101 mg/dL with postdilution
Predicate device: 0-25 mg/dL without postdilution; 0-250 mg/dL with postdilution
Lower detection limit:
Modified Device: 0.1 mg/dL
Predicate device: 0.063 mg/dL
Endogenous interferences (Bilirubin Special):
Same for both devices. Hemolysis: No significant interference up to 1000 mg/dL. Lipemia: No significant interference up to 1400 mg/dL as Intralipid.
Exogenous interferences:
Same for both devices. Ascorbic acid at 30 mg/dL causes artificially decreased total bilirubin values.
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.
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
§ 862.1110 Bilirubin (total or direct) test system.
(a)
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.(b)
Classification. Class II.
0
JAN 1 7 2007
Special 510(k) Summary
Purpose for Submission
Roche Diagnostics hereby submits this Special 510(k) to provide notification of modification to our Total Bilirubin Special test system. The reagent was originally cleared for use as:
-
. COBAS INTEGRA Total Bilirubin Special K981632/A001
And modified as COBAS INTEGRA Total Bilirubin Special K063543 ● Modifications to the test systems include: -
Reagent application to the cobas c 111 analyzer .
-
Other editorial labeling changes .
A full description of the differences and similarities between performance of Total Bilirubin Special on the COBAS INTEGRA 400 plus and cobas c 111 is described bclow.
The cobas c 111 analyzer is a new member of the COBAS INTEGRA® family of analyzers and will use reagents and calibrators identical to those of other INTEGRA analyzers. The cobas c 111 is a device modification of the current COBAS INTEGRA® 400 plus analyzer, cleared in a letter to file K951595. A full description of the differences and similarities between the two analyzers, software modifications and a summary of the design validation and verification activities for the modified software is included in this submission as part of the modifications to the Total Bilirubin Special test system.
In accordance with the FDA policy, new applications of previously cleared reagents to the cobas c 111 analyzer were completed, along with new labeling in the form of cobas c 111 package inserts. For all subsequent applications of previously cleared reagents, Roche Diagnostics is following the FDA guidance, Replacement Reagent and Instrument Family Policy - Dec 11, 2003, to demonstrate equivalence to the original reagent/instrument performance. Data will be available for FDA review upon request.
The additional labeling provided in this submission is for purposes of CLIA categorization.
Device Name Proprietary name: Total Bilirubin Special
Common name: Bilirubin total
Classification name: Bilirubin (total or direct) test system
Continued on next page
1
| Establishment
Registration | The establishment registration number for Roche Diagnostics Gmbh Penzberg
is 9610529. | | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------|------------------------|
| | The establishment registration number for Roche Diagnostics Corporation is
1823260. | | | |
| | The establishment registration number for Roche instrument Center (RIC) is
3003795116. | | | |
| Classification | The FDA has classified a discrete photometric chemistry analyzer in Class I. | | | |
| | Panel | Classification
Number | Classification
Name | Regulation
Citation |
| | 75 Clinical
Chemistry | CIG | Bilirubin (total or
direct) test system | 21 CFR 862.111
0 |
| Device
Description | The Total Bilirubin Special reagent is intended for use on the cobas c 111
analyzer for the quantitative determination of total or direct bilirubin in serum
and plasma.
The cobas c 111 analyzer is a partially automated, in-vitro diagnostic
analyzer capable of performing clinical chemistry, specific protein and
electrolyte tests. Analytes are measured photometrically or turbidimetrically;
the analyzer also has an optional ISE module for measuring sodium,
potassium and chloride.
The cobas c 111 instrument is a random access analyzer designed to be
operated on a bench top in the professional environment using a combination
of a photometric analysis unit and an optional ion selective electrodes (ISE). | | | |
| Performance
Standards | To date, no performance standards that affect this device have been finalized
under Section 514 of the Act. | | | |
| Intended use | In vitro test for the quantitative determination of total bilirubin in human
serum and plasma on the cobas c 111 system. | | | |
| Predicate
device | We claim substantial equivalence to the Total Bilirubin Special reagent
cleared as K063543. | | | |
2
Substantial equivalency-Similarities
The table below indicates the similarities and differences between the modified Bilirubin total reagent and its predicate device.
| Feature | Modified Device:
Total Bilirubin Special | Predicate device:
COBAS INTEGRA Total Bilirubin
Special, K063543 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Intended Use/
Indications for
Use | In vitro test for the quantitative
determination of total bilirubin in
human serum and plasma on the
cobas c 111 system. | 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). |
| Specimen | serum and plasma | serum and plasma |
| Test Principle | | |
| Reference
method | Same | Diazo method |
| Reagent information | | |
| Reagent
composition | Same | R1: Sodium acetate buffer 85
mmol/L, Sulfamic acid 110 mmol/L
R2: Hydrochloric acid 100 mmol/L,
Diazonium ion 3 mmol/L |
| Stability - shelf
life and on-
board | 2-8 °C until expiration date
On-board 4 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 |
| Calibrator | Same | Calibrator f.a.s. |
| Quality control | Same | Precinorm U, Precipath U
Precinorm U plus, Precipath U plus |
| Traccability | Same | Standardized against the Doumas
reference method |
| Performance characteristics | | |
| Precision | Within-run
1.79% @ 21.7 µmol/L
0.64% @ 64.2 µmol/L
2.94% @ 15.2 µmol/L
0.77% @ 60.0 µmol/L
Total
2.32% @ 21.6 µmol/L
0.71% @ 67.4 µmol/L
3.10% @ 16.2 µmol/L
0.79% @ 83.0 µmol/L | 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 |
| Measuring | 0.1-25.2 mg/dL | 0-25 mg/dL |
| Measuring range | 0.1-101 mg/dL (with postdilution) | 0-250 mg/dL (with postdilution) |
| Lower detection
limit | 0.1 mg/dL | 0.063 mg/dL |
| Expected values
(literature
reference) | Same | 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 |
| Endogenous | Same | 3-5 days: 4.0-12.0 mg/dL
Hemolysis: No significant |
| interferences | | interference up to 1000 mg/dL
Lipemia: No significant interference
up to 1400 mg/dL as Intralipid |
| Exogenous
interferences | Same | Ascorbic acid at 30 mg/dL causes
artificially decreased total bilirubin
values |
| | | Analyzer |
| Topic | cobas c 111 Analyzer
(Modified Device) | COBAS INTEGRA® 400 plus
with ISE
(K951595) |
| | | Analyzer Description |
| Intended Use | The Roche cobas c 111 analyzer is
an in-vitro diagnostic analyzer
capable of performing clinical
chemistry, specific protein and
electrolyte tests. Analytes are
measured photometrically or
turbidimetrically; the analyzer also
has an optional ISE module for
measuring sodium, potassium and
chloride. | The Roche COBAS INTEGRA 400
plus is an automated in vitro
diagnostic analyzer capable of
performing general chemistry,
specific protein, electrolyte tests,
therapeutic drug, drug of abuse and
thyroid analyses. It is equipped with
modules for absorption photometry,
fluorescence polarization
photometry and potentiometry (ISE)
and works in conjunction with in
vitro diagnostic reagents. |
| Analyzer Description (continued) | | |
| Measurement
principle | • Absorbance Photometry
(enzymes, substrates,
proteins)
• ISE Potentiometry
(electrolytes) | • Absorbance Photometry
(enzymes, substrates,
proteins, DAT)
• Fluorescence Photometry
(TDM)
• ISE Potentiometry
(electrolytes) |
| Reaction
modes | Same | Endpoint, kinetic, potentiometric |
| Software SIMILARITIES | | |
| Software | cobas c 111 analyzer software | Cobas Integra® 400 plus Analyzer
Software |
| Configuration | Integrated bench top analyzer
(including Absorbance Photometer)
with optional ISE unit | Integrated benchtop analyzer (incl.
Abs, FP-Photometer & ISE module) |
| Functions
performed | Same | Data input, sample processing, result
calculation, result reporting, quality
control |
| Computer | Data management & user interaction | Data management & user interaction |
| Infrastructure | on cmbedded CPU with Linux | on PC based computer with |
| | operating analyzer | Windows XP operating analyzer |
| | Instrument management and real- | Instrument management and real- |
| | time control on cmbedded CPU with | time control on embedded CPU with |
| | vxWorks operating analyzer | vxWorks operating analyzer |
| Analytical | Same | Control of analytical processes |
| Functions | | (pipetting, incubation, detection), |
| | | primary signal processing |
| Data storage | Same but no patient demographies | Storage of analyzer and application |
| | are stored (due to less storage
capacity). | parameters, calibration data, QC |
| | | data, sample results, alarms, patient |
| | | demographics, service actions and |
| Result | Same | status information |
| calculation | | Automated measuring of signal for
kinetic and endpoint methods |
| | | according to cycle time and |
| | | automated calculation of |
| | | concentration via calibration curve |
| User | Same | User ID and password |
| management | | |
| Flagging of | Same | Available |
| errors | | |
| | | |
| Software DIFFFRENCES | | |
| Initial cassette | Not applicable: | |
| volume check | | Available |
| (ICVC) for | Instead of cassettes single bottles | |
| reagent | with liquid level detection are used | |
| pipetting | | |
| Data concept | Applications via barcode | |
| (Application | | Applications via diskette |
| parameter | | |
| transfer) | | |
| Data concept | Automatic QC when QC samples | Automatic QC with on board QC |
| (Cal/QC | are placed manually | samples |
| assigned values) | | |
| Analyzer Features | | |
| Throughput | Max 100 tests per hour | Max 400 tests per hour |
| Analyzer Size | Same but smaller | Integrated benchtop analyzer |
| Sample Handling | | |
| Typical sample | Typically 2 - 10 µL per test (same) | Typically 2 - 10 µL per test |
| volumes | ISE (serum, plasma): | ISE (serum, plasma): |
| | 25 µL (indirect mode) | 20 uL (indirect mode) |
| | ISE (urine): | 97 uL (direct mode) |
| | 25 µL (indirect mode): | ISE (urine):
20 µL (indirect mode): |
| Sample Types | Same, but not CSF | Serum, plasma, urine, CSF; whole blood and hemolysate for HbAlc |
| Sample
Handling
Analyzer | Sample area for samples, calibrators and controls. | Rack analyzer for samples, calibrators and controls. |
| Sample capacity
on board | 8 places for cups / tubes. | Up to six racks with max. 15 sample cups/tubes per rack on board. |
| Sample
identification | Same | ID- Barcode |
| Reagent Handling | | |
| Reagent
Volume | Same | 20 – 150 μL |
| Reagent
Container | Unisys 20mL bottle | Integra cassette / cobas c pack |
| Reagent
Container
(Electrolytes) | Same | Plastic bottles closed with screwcaps |
| Reagent Access | Manual opening of bottle prior to
placement on board | Reagent cassette caps pierced automatically inside the instrument. |
| Onboard
storage
temperature | Refrigerated 6-10 °C (43-50 °F) | Refrigerated 10 - 15 °C (50-59 °F) |
| Reagent
bottle/cassette
identification | Same | Barcode |
| On board
reagent storage
capacity | 27 reagent bottles | 32 cassettes |
| Analyzer cycle
time | 18 sec | 10.6 sec |
| Reagent mixing | Stirring in cuvette with steel probe | Integrated cuvette vortex mixer |
| Auto rerun | Manual only | Available |
| Pipetting Analyzer | | |
| Sample and
reagent syringes | XZ-Phi robotic syringe | XYZ robotic syringe |
| Reagent probes | 1 polished steel probe with modified
design (used for sample & reagent) | 2 polished steel probes (used for
sample & reagent) |
| Sample probes | 1 polished steel probe with modified
design (used for sample & reagent) | 2 polished steel probes (used for
sample & reagent) |
| Probe cleaning | Same | Automatic incl. carry over evasion |
| Liquid level
detection | Same (+ reagent pipetting) | Both probes conductance for sample
pipetting |
| Clot detection | Not available | Available - pressure sensor |
| Test Reaction Chamber | | |
| Temperature
Control | Same | Heated air bath 37 °C (99 °F) |
| Cuvettes | Same | PMMA acrylic plastic – for single
use |
| ISE Module | | |
| ISE Module | Serum, plasma indirect (1:6 dilution)
Urine indirect (1:6 dilution)
One-point calibration every sample
measurement. | Serum, plasma direct (undiluted)
Serum, plasma indirect (1:6 dilution)
Urine indirect (1:6 dilution)
One-point calibration every sample
measurement. |
| Ion Selective
Electrodes | Same but no lithium electrode | Potentiometric: chloride, potassium,
sodium, lithium and reference
electrode |
| ISE throughput | 60 samples / h | 66 samples / h |
| Detection Information | | |
| Spectrophotometer | Same | Grating monochromator and diode
array |
| Light source | Tungsten / Halogen lamp, 20 W | Tungsten / Halogen lamp, 100 W |
| Light path | Same | 5 mm path length |
| Measuring unit | Same | Intensity (0 - 2.0 A) |
| Wavelengths | 340, 378, 409, 449, 480, 512,
520, 552, 583, 629, 652, 659 nm
mono- and bichromatic
measurements | 340, 378, 409, 480, 512, 520,
552, 583, 629, 652, 659, 800 nm
mono- and bichromatic
measurements |
| Calibration and quality control | | |
| Calibrators | Same | Multiple use |
| Calibration
modes | Same | Linear, non linear. Multiple
standards. Generation of multipoint
standard curves by automatic
dilution. |
| Calibration / on
board stability | Same | Typically each lot or 12 weeks for
same reagent on board |
| Control storage
on instrument | To be placed on demand | Within sample area possible |
| Calibrator /
control value
transfer | Same | Via barcode transfer sheet or manual
entry |
| Internal quality
management
analyzer | Same | Available to monitor and validate
test results |
| Interfaces | | |
| Host interface | Same | RS232C bi-directional |
| Printer | Internal thermo paper printer | Standalone LaserJet type |
| Display | Internal LCD touch panel (1/4 VGA size) | Standalone 17" computer display w. keyboard and mouse |
3
.
4
5
6
7
8
| Proposed
Labeling | Total Bilirubin Special reagent:
Proposed labeling sufficient to describe the device, its intended use, and the
directions for use can be found in the separately attached document. We
believe the proposed version of the device labeling presented contains all of
the technical information required per 21 CFR 809.10. | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | cobas c 111 analyzer:
Draft cobas c111 method manual sheets and example cassette labels for
CLIA categorization purposes in this submission. | |
| | A complete User's Manual for the cobas c111 analyzer is provided in
Volume II of this submission. | |
| | A CD-ROM containing the COBAS INTEGRA 400 plus Operator's Manual
(the predicate device for cobas c 111 analyzer) is included with this
submission. | |
| | 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 Results of
Risk Analysis and Declaration of Conformity with Design Controls are
provided with this submission. | |
| Confidentiality | Roche Diagnostics requests that the FDA not disclose the nature or existence
of this submission until the substantial equivalence decision has been
reached. | |
9
Closing Modification of the Bilirubin Total reagent does not affect the 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 to its predicate for the Total Bilirubin Special application to cobas c 111 analyzer.
An clectronic copy (scanned pdf version) of this submission can be provided upon request. 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(a roche.com
Sincerely,
Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics Corporation
10
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Attn: Corina Harper
JAN 17 2007
Re: K063744 Trade/Device Name: Total Bilirubin Special Regulation Number: 21 CFR §862.1110 Regulation Name: Bilirubin (total or direct) test system. Regulatory Class: Class II Product Code: CIG Dated: December 15, 2006 Received: December 18, 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, youg, 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, l'inte 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 revire 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 madon toos not incant 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 Prt 820).
11
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 vours.
Jean m. Cooper, M.S., D.V.M.
Yean 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
12
Indications for Use
510(k) Number (if known): K063744
Device Name: Total Bilirubin Special
Indications For Use:
In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system.
Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.
Prescription Use XXX AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 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)
Page 1 of 1
Carol C. Bener
Vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
4062744