ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
Device Facts
| Record ID | K972250 |
|---|---|
| Device Name | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Aug 12, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
Indications for Use
COBAS INTEGRA Ammonia (NH3): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045). COBAS INTEGRA aAmylase EPS (AMYLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999). COBAS INTEGRA Cholesterol (CHOLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol (test CHOLL, 0-001) and HDL cholesterol concentration in serum and plasma in clinical laboratories. COBAS INTEGRA HDL Cholesterol Application (HDLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol and HDL - cholesterol (test HDLL, 0-002) concentration in serum and plasma in clinical laboratories. COBAS INTEGRA Creatinine Enzymatic (CREAE): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the creatinine concentration in serum (test CREAE, 0-014), and urine (test CREEU, 0-114). COBAS INTEGRA Digitoxin (DIGIT): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of digitoxin in serum or heparinized plasma (test DIGIT 0-259). COBAS INTEGRA Gamma Glutamyltransferase (GGTL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTL, 0-599). COBAS INTEGRA Glucose HK Liquid (GLUCL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma (test GLUL, 0-991), urine (test GLULU, 0-992), and cerebrospinal fluid (test GLULC, 0-993). COBAS INTEGRA Lipase (LIPL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of lipase in serum and plasma (test LIPL, 0-200). COBAS INTEGRA Lysergic acid diethylamide (LSD): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the qualitative determination of lysergic acid diethylamide (LSD) in urine (test LSD, 0-001). COBAS INTEGRA Urea/BUN (UREAL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the urea/BUN (blood urea nitrogen), in serum, plasma (test UREL, 0-003) and urine (test URELU, 0-004). Roche TDM OnLine Digitoxin Calibrators: are intended for use with the Roche reagents for Digitoxin and the COBAS Chemistry systems for the quantitative determination of digitoxin in serum and plasma. Roche TDM OnLine Digitoxin Controls: are quality control samples intended for use on COBAS chemistry systems with Roche reagents and calibrators for the quantitative determination of digitoxin assays.
Device Story
COBAS INTEGRA system uses reagent cassettes for automated in vitro diagnostic testing; analyzer performs chemistry, drugs of abuse, immunology, and TDM assays. System utilizes absorbance, fluorescence polarization, and ion-selective electrodes; throughput up to 600 tests/hour. Reagent cassettes are barcode-identified, preparation-free, and stored on-board at 2-8°C. Input samples (serum, plasma, urine, CSF) are processed via robotics; analyzer provides quantitative or qualitative results to clinicians. System streamlines workflow via random access and STAT prioritization. Benefits include improved time management, reduced manual preparation, and consistent diagnostic accuracy for clinical decision-making.
Clinical Evidence
Bench testing only. Performance evaluated via precision (within-run and total CV%), sensitivity, and accuracy (correlation with predicate methods). Sample sizes ranged from 114 to 256. Correlation coefficients (r) were consistently high (0.973–0.999). Results confirm performance is equivalent to legally marketed predicate devices.
Technological Characteristics
Automated analyzer using absorbance, fluorescence polarization, and ion-selective electrodes. Reagents are liquid-based (previously granulate). Methodology includes enzymatic colorimetric, kinetic interaction of microparticles in solution (KIMS), and turbidimetric methods. System features barcode readers for reagent/sample identification, on-board refrigerated storage (2-8°C), and robotic sample handling. Connectivity includes automated data reading from cassette labels.
Indications for Use
Indicated for quantitative or qualitative in vitro diagnostic determination of analytes (Ammonia, Amylase, Cholesterol, HDL-Cholesterol, Creatinine, Digitoxin, GGT, Glucose, Lipase, LSD, Urea/BUN) in human serum, plasma, urine, or CSF. Used in clinical laboratory settings for patient monitoring and diagnostic testing.
Regulatory Classification
Identification
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Predicate Devices
- Roche Reagent for Ammonia (K913124)
- COBAS INTEGRA αAmylase (Granulate) (K951595)
- COBAS INTEGRA Cholesterol (Granulate) (K951595)
- COBAS INTEGRA HDL-Cholesterol (Granulate) (K951595)
- COBAS INTEGRA Creatinine (Kinetic Jaffe) (K951595)
- Abbott Diagnostics, TDX / TDX Flex Digitoxin Reagent (K842280)
- COBAS INTEGRA Lipase (Granulate) (K951595)
- COBAS INTEGRA Glucose HK (Granulate) (K951595)
- COBAS INTEGRA Urea (Granulate) (K951595)
- Abbott Diagnostics, TDX / TDX Flex Digitoxin Calibrators (K842280)
- Abbott Diagnostics, TDX / TDX Flex Digitoxin Controls (K842280)
Submission Summary (Full Text)
{0}------------------------------------------------
912250
Roche
AUG 1 2 1997
# 510(k) Summary
# Roche COBAS® INTEGRA Reagent Cassettes
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
#### Identification of 510(k) Sponsor: I.
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated June 13, 1997
Maria Feijoo Contact: Regulatory Affairs Associate Phone: (908) 253-7310 (908) 253-7547 Fax:
{1}------------------------------------------------
#### II. Device Name:
/
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Proprietary Name | Classification Name | Product Code | Regulation Number |
|----------------------------------|--------------------------------------------------------------------------------------------------------------|--------------|-------------------|
| | | | |
| COBAS INTEGRA... | | | |
| Ammonia | Ammonia test system,<br>Enzymatic method | JIF | 862.1065 |
| αAmylase EPS | Amylase test system,<br>Catalytic method | JFJ | 862.1070 |
| Cholesterol | Cholesterol test system,<br>Enzymatic esterase - oxidase<br>method | CHH | 862.1175 |
| HDL-Cholesterol | Lipoprotein test system,<br>Phosphotungstic acid method | N/A | 862.1475 |
| Creatinine | Creatinine test system,<br>Enzymatic method | JFY | 862.1225 |
| Digitoxin | Digitoxin test system,<br>Kinetic interaction of<br>microparticles in solution method | DKQ | 862.3300 |
| Gamma-Glutamyltransferase (GGT) | Gamma-glutamyl transpeptidase and isoenzymes test system,<br>Kinetic method | JQB | 862.1360 |
| Glucose HK | Glucose test system,<br>Enzymatic method | CFR | 862.1345 |
| Lipase | Lipase test system,<br>Turbidimetric method | CET | 862.1465 |
| Lysergic acid diethylamide (LSD) | Lysergic acid diethylamide (LSD) test system,<br>Kinetic interaction of<br>microparticles in solution method | N/A | 862.3580 |
| Urea | Urea nitrogen test system,<br>Kinetic urease method | CDQ | 862.1770 |
| Roche TDM OnLine... | | | |
| Digitoxin Calibrators | Clinical toxicology calibrator,<br>Drug specific | DLJ | 862.3200 |
| Digitoxin Controls | Clinical toxicology control<br>material,<br>Drug specific | LAS | 862.3280 |
| able<br>œ<br>5 | |
|----------------|--|
|----------------|--|
{2}------------------------------------------------
1
#### III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| Product Name | Predicate Product Name | K number | Date of<br>substantial<br>equivalence |
|----------------------------------|-------------------------------------------------------------|----------|---------------------------------------|
| COBAS INTEGRA... | | | |
| Ammonia | Roche Reagent for Ammonia | K913124 | 8/12/91 |
| αAmylase EPS (Liquid) | COBAS INTEGRA αAmylase (Granulate,<br>CL-PNP-G, method) | K951595 | 9/8/95 |
| Cholesterol (Liquid) | COBAS INTEGRA Cholesterol (Granulate) | K951595 | 9/8/95 |
| HDL - Cholesterol (Liquid) | COBAS INTEGRAHDL - Cholesterol<br>(Granulate) | K951595 | 9/8/95 |
| Creatinine (Enzymatic) | COBAS INTEGRA Creatinine (Kinetic<br>Jaffe) | K951595 | 9/8/95 |
| Digitoxin | Abbott Diagnostics, TDX / TDX Flex<br>Digitoxin Reagent | K842280 | 8/16/84 |
| Gamma-Glutamyltransferase (GGT) | COBAS INTEGRA Lipase (Granulate) | K951595 | 9/8/95 |
| Glucose HK | COBAS INTEGRA Glucose HK (Granulate) | K951595 | 9/8/95 |
| Lipase | COBAS INTEGRA Lipase (Granulate) | K951595 | 9/8/95 |
| Lysergic acid diethylamide (LSD) | | | |
| Urea | COBAS INTEGRA Urea (Granulate) | K951595 | 9/8/95 |
| Roche TDM OnLine ... | | | |
| Digitoxin Calibrators | Abbott Diagnostics, TDX / TDX Flex<br>Digitoxin Calibrators | K842280 | 8/16/84 |
| Digitoxin Controls | Abbott Diagnostics, TDX / TDX Flex<br>Digitoxin Controls | K842280 | 8/16/84 |
| 11<br>C | abl<br>ાર | 1 |
|---------|-----------|---|
| | | |
#### IV. Description of the Device/Statement of Intended Use:
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer along with 96 other Roche COBAS INTEGRA Reagent Cassettes were previously cleared on September 8, 1995 (K951595); January 25, 1996 (K954992); July 23, 1996 (K961824); October 31, 1996 (K963292); and January 21, 1997 (K964457).
{3}------------------------------------------------
The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8℃. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents. For additional information on the COBAS INTEGRA Analyzer and its constituent modules, please refer to the Operator's Manual in Volumes 1 through 2, pages 92-703, of the original 510(k) submission (K951595).
Through this submission, it is the intention of Roche Diagnostic Systems to gain clearance for an additional 4 COBAS INTEGRA Reagent Cassettes and 2 ancillary reagents as well as modifications to 7 previously cleared COBAS INTEGRA Reagent Cassettes. These reagents have been modified from granulate to liquid form.
## The new Reagent Cassettes and ancillary reagents are:
### COBAS INTEGRA Ammonia (NH3):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045).
# COBAS INTEGRA Creatinine Enzymatic (CREAE):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the creatinine concentration in serum (test CREAE, 0-014), and urine (test CREEU, 0-114).
### COBAS INTEGRA Digitoxin (DIGIT):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of digitoxin in serum or heparinized plasma (test DIGIT 0-259).
### Roche TDM OnLine Digitoxin Calibrators:
are intended for use with the Roche reagents for Digitoxin and the COBAS Chemistry systems for the quantitative determination of digitoxin in serum and plasma.
{4}------------------------------------------------
Roche Diagnostic Systems, Inc. Somerville, New Jersey 08876 June 1997
## Roche TDM OnLine Digitoxin Controls:
are quality control samples intended for use on COBAS chemistry systems with Roche reagents and calibrators for the quantitative determination of digitoxin assays.
# COBAS INTEGRA Lysergic acid diethylamide (LSD):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the qualitative determination of lysergic acid diethylamide (LSD) in urine (test LSD, 0-001)
The modified Reagent Cassettes are:
# COBAS INTEGRA aAmylase EPS (AMYLL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999).
## COBAS INTEGRA Cholesterol (CHOLL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol (test CHOLL, 0-001) and HDL - cholesterol concentration in serum and plasma in clinical laboratories.
## COBAS INTEGRA HDL - Cholesterol Application (HDLL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol and HDL - cholesterol (test HDLL, 0-002) concentration in serum and plasma in clinical laboratories.
# COBAS INTEGRA Gamma - Glutamyltransferase (GGTL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTL, 0-599).
# COBAS INTEGRA Glucose HK Liquid (GLUCL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma (test GLUL, 0-991), urine (test GLULU, 0-992), and cerebrospinal fluid (test GLULC, 0-993).
# COBAS INTEGRA Lipase (LIPL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of lipase in serum and plasma (test LIPL, 0-200).
{5}------------------------------------------------
# COBAS INTEGRA Urea/BUN (UREAL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the urea/BUN (blood urea nitrogen), in serum, plasma (test UREL, 0-003) and urine (test URELU, 0-004).
The clinical utility and methodology of each reagent cassette are further described in the test specific COBAS INTEGRA Method Manual sheets, contained in the test specific sections of this submission.
#### V. Summary of the technological characteristics of the new device in comparison to those of the predicate.
Tables 3-13 outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagents in comparison to those of legally marketed predicate products.
#### VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 3-13 demonstrate the results of clinical and nonclinical studies performed using the COBAS INTEGRA Reagent Cassettes. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to other legally marketed devices of a similar kind.
{6}------------------------------------------------
・
, de
# Table 3 - Ammonia (NH3)
| | COBAS INTEGRA Ammonia | | Roche Reagent for Ammonia | |
|------------------------------|-----------------------------------|-------------|-----------------------------------|---------|
| Intended Use | quantitative determination of the | | quantitative determination of the | |
| | ammonia concentration | | ammonia concentration | |
| Sample type | plasma | | plasma | |
| Methodology | enzymatic, with glutamate | | enzymatic, with glutamate | |
| | dehydrogenase | | dehydrogenase | |
| Reagents | R1: Enzyme (liquid) | | R1: Enzyme (liquid) | |
| | R2: Coenzyme (liquid) | | R2: Coenzyme (liquid) | |
| Calibrator | Roche Ammonia/Ethanol/CO, | | Roche Ammonia/Ethanol/CO. | |
| | Calibrator | | Calibrator | |
| Controls | Roche Ammonia/Ethanol Controls | | Roche Ammonia/Ethanol Controls | |
| Performance Characteristics: | | | | |
| Assay Range | 0 - 700 umol/L (0 - 1190 ug/dL ) | | 0 - 700 U/L | |
| | | | 0 - 2,800 U/L with postdilution | |
| Precision: | Level 1 | Level 2 | Level 1 2 | Level 2 |
| Mean (umol/L) | 48.8 | 226 | ર્દિવ | 211 |
| | (83.0 ug/dL) | (384 ug/dL) | | |
| %CV (within run) | 3.1 | 2.0 | 5.7 | 1.9 |
| %CV (total) | 5.2 | 2.5 | 8.8 | 5.9 |
| Sensitivity | 0.76 AA per umol/L | | 0.0009 AA per umol/L | |
| Accuracy: | | | | |
| Sample size (n) | 164 | | વેરૂ | |
| Corr. Coefficient (r) | 0.997 | | 0.992 | |
| Lin. Regression | 1.03x - 2.8 umol/L vs. Roche | | 1.02x + 3.2 umol/L | |
| | Reagent for Ammonia | | | |
{7}------------------------------------------------
# Table 4 - Creatinine (CREAE)
| | COBAS INTEGRA Creatinine<br>(Enzymatic, PAP) | COBAS INTEGRA Creatinine<br>(Kinetic, Jaffé) |
|--------------|----------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended Use | quantitative determination of the catalytic<br>activity of a amylase | quantitative determination of the catalytic<br>activity of a amylase |
| Sample type | serum, plasma and urine | serum, plasma and urine |
| Methodology | enzymatic colorimetric method (PAP) | Jaffé, buffered, kinetic method |
| Reagents | R1: Enzyme (liquid)<br>R2: Substrate (liquid) | R1: Alkaline buffer (liquid)<br>R2: Picric acid (liquid) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P (human) | Roche Control Serum N and P (human) |
## Performance Characteristics for serum and plasma:
| Assay Range | 0 - 2000 µmol/L (0-22.6 mg/dL)<br>0 - 20000 µmol/L (0-226 mg/dL) with post dilution | 0 - 1300 µmol/L (0-15 mg/dL)<br>0 - 13000 µmol/L (0-1470 mg/dL) with post dilution | | |
|-----------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (µmol/L) | 99.4<br>(1.1mg/dL) | 535<br>(6.0 mg/dL) | 85.5<br>(0.97mg/dL) | 624<br>(7.1 mg/dL) |
| %CV (within run) | 1.6 | 0.88 | 1.5 | 1.1 |
| %CV (total) | 2.2 | 1.5 | 1.9 | 1.5 |
| Sensitivity | 2.2 X 10-4 ΔA per µmol/L<br>(1.9 X 10-4 ΔA per mg/dL) | | 8.0 X 10-5 ΔA/min per µmol/L<br>(1.7 X 10-3 ΔA/min per mg/dL) | |
| Accuracy: | | | | |
| Sample size (n) | 238 | | 256 | |
| Corr. Coefficient (r) | 0.999 | | 0.999 | |
| Lin. Regression | 1.08x - 30.6 µmol/L vs. COBAS<br>INTEGRA Creatinine (Jaffé) | | 0.87x - 2 µmol/L | |
## Performance Characteristics for urine:
| Assay Range | 0 - 40 mmol/L (0-450 mg/dL)<br>0 - 200 mmol/L (0-2260 mg/dL) with post<br>dilution | 0 - 32.5 mmol/L (0-367 mg/dL)<br>0 - 130 mmol/L (0-1470 mg/dL) with post<br>dilution | | |
|-----------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------|-------------------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmo/L) | 4.1<br>(46.7 mg/dL) | 14.0<br>(159 mg/dL) | 5.3<br>(60 mg/dL) | 19<br>(216 mg/dL) |
| %CV (within run) | 0.88 | 0.87 | 1.5 | 1.0 |
| %CV (total) | 1.1 | 0.93 | | |
| Sensitivity | $5.7 X 10^{-3}$ ΔA per mmol/L<br>( $5.1 X 10^{-2}$ ΔA per mg/dL) | Not specified in labeling | | |
| Accuracy: | | | | |
| Sample size (n) | 116 | Not specified in labeling | | |
| Corr. Coefficient (r) | 0.999 | | | |
| Lin. Regression | 0.99x -0.28 mmol/L vs. COBAS<br>INTEGRA Creatinine (Jaffé) | | | |
{8}------------------------------------------------
Lin. Regression
く
1.060 + 0.729 ng/mL
# Table 5 - Digitoxin Reagent, Calibrators, and Controls (DIGIT)
| COBAS INTEGRA Digitoxin &<br>Roche - TDM OnLine Digitoxin<br>Calibrators & Controls | | | Abbott TDx/TDxFLx Digitoxin<br>Reagent, Calibrators & Controls | | | |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------|---------------------|-----------------------|------------------------|
| Intended Use | quantitative determination of digitoxin | | quantitative determination of digitoxin | | | |
| Sample type | serum and heparinized plasma | | serum and plasma | | | |
| Methodology | kinetic interaction of microparticles in<br>solution (KIMS) | | fluorescence polarization (FPIA) | | | |
| Reagents | R1: Anti-digitoxin monoclonal antibody<br>(mouse) in buffer (liquid)<br>R2: Conjugated digitoxin derivative<br>microparticles in buffer (liquid) | | R1: Digitoxin Antiserum (Rabbit) in<br>buffer<br>R2: Digitoxin Fluorescein tracer in buffer | | | |
| Calibrator Levels<br>(in human serum) | 0, 7.5, 15, 30, 45, 65 ng/mL | | 0, 5.0, 10.0, 20.0, 40.0, 80.0 ng/mL | | | |
| Controls Levels<br>(ng/mL)<br>(in human serum) | Level 1<br>12.0 - 18.0 | Level 2<br>24.0 - 36.0 | Level 3<br>36.0 - 54.0 | Level 1<br>5.4- 9.6 | Level 2<br>12.0- 18.0 | Level 3<br>26.5 - 43.5 |
| Performance Characteristics: | | | | | | |
| Assay Range | 2.0 - 65 ng/mL | | 2.0 - 80 ng/mL | | | |
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (ng/mL) | 10.4 | 19.5 | 37.1 | 7.5 | 15.0 | 35.0 |
| % CV (within run) | 6.0 | 3.9 | 3.6 | 7.05 | 4.87 | 4.72 |
| %CV (total) | 7.4 | 4.5 | 3.7 | 10.61 | 7.19 | 8.46 |
| Sensitivity | 2.0 ng/mL | | | 2.0 ng/mL | | |
| Accuracy:<br>Sample size (n) | 232 | | | 178 | | |
| Corr. Coefficient (r) | 0.973 | | | 0.967 | | |
0.945x + 1.19 ng/mL vs. Abbott
TDx/TDxFLx Digitoxin
1 039
{9}------------------------------------------------
# Table 6 - Lysergic acid diethylamide (LSD)
| | COBAS INTEGRA LSD | Roche Abuscreen RIA for LSD |
|--------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | qualitative detection of LSD and its<br>metabolites | detection of LSD and its metabolites |
| Sample type | urine | urine |
| Methodology | kinetic interaction of microparticles in<br>solution (KIMS) | competitive binding to antibody of ¹²⁵I-<br>radiolabeled antigen and unlabeled<br>antigen |
| Cutoff | 0.5 ng/mL | 0.5 ng/mL |
| Reagents | R1: Buffer<br>R2: conjugated LSD derivative<br>microparticles in buffer<br>R3: LSD polyclonal antibody (goat) in<br>buffer | R1: LSD polyclonal (rabbit) antibody in<br>buffer<br>R2: ¹²⁵I-LSD in buffer<br>R3: Anti-rabbit immunoglobulin serum<br>(goat) in buffer |
| Calibrator | Roche Abuscreen Calibration Standard | Roche Abuscreen Calibration Standard |
| Controls | Roche Abuscreen Reference Controls<br>and Calibrator | Roche Abuscreen Reference Controls<br>and Calibrator |
# Performance Characteristics:
ે છ
| Assay Range | 0 - 1 ng/mL | | | 0 - 1 ng/mL | | | | |
|------------------|---------------------------------------|---------|---------|-------------|---------------------------------------|-------------|-------------|--|
| Precision: | Level 1 | Level 2 | Level 3 | L1<br>ng/mL | L2<br>ng/mL | L3<br>ng/mL | L4<br>ng/mL | |
| Mean | O.D. | O.D. | O.D. | 0.0 | 0.25 | 0.5 | 1.0 | |
| %CV (within run) | 0.978 | 0.913 | 0.870 | 0.6 | 1.3 | 1.6 | 1.8 | |
| Sensitivity | 0.10 ng/mL of LSD at > 95% confidence | | | | 0.25 ng/mL of LSD at > 99% confidence | | | |
| Accuracy: | | | | | | | | |
| Positive Samples | INTEGRA | GC/MS | RIA | | GC/MS | | RIA | |
| | +<br>39<br>-<br>0 | 39<br>0 | 39<br>0 | + | 21 | | 21<br>0 | |
{10}------------------------------------------------
# Table 7 - α- Amylase (AMYLL)
| | COBAS INTEGRA α - Amylase<br>EPS (Liquid) | COBAS INTEGRA α - Amylase<br>(Granulate) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of the<br>catalytic activity of α amylase | quantitative determination of the<br>catalytic activity of α amylase |
| Sample type | serum, plasma and urine | serum, plasma and urine |
| Methodology | enzymatic colorimetric method<br>using the substrate 4,6-ethylidene<br>-p-nitrophenyl-α,D-<br>maltoheptaoside | enzymatic colorimetric method with 2-<br>chloro -4-nitrophenyl-β-D-<br>maltoheptaoside |
| Reagents | R1: Enzyme (liquid)<br>R2: Substrate (liquid) | R1: Enzyme (granulate)<br>R2: Substrate (granulate) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P<br>(human) | Roche Control Serum N and P<br>(human) |
| Performance Characteristics for serum and plasma: | | |
| Assay Range | 0 - 2000 U/L<br>0 - 10000 U/L with post dilution | 0 - 2000 U/L<br>0 - 20000 U/L with post dilution |
| Precision:<br>Mean (U/L) | Level 1<br>76 | Level 2<br>498 |
| | Level 1<br>143 | Level 2<br>277 |
| Mean (U/L) | 76 | 498 | 143 | 277 |
|-----------------------|---------------------------------|-----|---------------------------|-----|
| %CV (within run) | 1.6 | 1.3 | 1.6 | 1.1 |
| %CV (total) | 2.3 | 2.6 | 1.6 | 2.0 |
| Sensitivity | 1.9 X 10-4 ΔA/min per U/L | | 1.5 X 10-4 ΔA/min per U/L | |
| Accuracy: | | | | |
| Sample size (n) | 114 | | 212 | |
| Corr. Coefficient (r) | 0.996 | | 0.992 | |
| Lin. Regression | 0.43x + 4 U/L vs. COBAS | | 0.98x - 19 U/L | |
| | INTEGRA α - Amylase (granulate) | | | |
# Performance Characteristics for urine:
| Assay Range | 0 - 2000 U/L<br>0 - 10000 U/L with post dilution | | 0 - 2000 U/L<br>0 - 20000 U/L with post dilution | |
|-----------------------|------------------------------------------------------------|---------|--------------------------------------------------|---------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (U/L) | 183 | 603 | 22 | 302 |
| %CV (within run) | 1.3 | | 2.5 | 0.56 |
| %CV (total) | 1.7 | 1.6 | | |
| Sensitivity | 1.9 X 10-4 ΔA/min per U/L | | Not specified in labeling | |
| Accuracy: | | | | |
| Sample size (n) | 150 | | Not specified in labeling | |
| Corr. Coefficient (r) | 0.988 | | | |
| Lin. Regression | 0.44x + 0 U/L vs. COBAS<br>INTEGRA α - Amylase (granulate) | | | |
{11}------------------------------------------------
# Table 8 - Cholesterol (CHOLL)
| | COBAS INTEGRA Cholesterol<br>(Liquid) | COBAS INTEGRA Cholesterol<br>(Granulate) |
|------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of total<br>cholesterol & HDL cholesterol | quantitative determination of total<br>cholesterol & HDL cholesterol |
| Sample type | serum and plasma | serum and plasma |
| Methodology | enzymatic, colorimetric method<br>using cholesterol esterase,<br>cholesterol oxidase and 4-<br>aminoantipyrine | enzymatic, colorimetric method using<br>cholesterol esterase, cholesterol oxidase<br>and 4-aminoantipyrine |
| Reagents | R: Cholesterol esterase, cholesterol<br>oxidase and 4-aminoantipyrine<br>(liquid) | R: Cholesterol esterase, cholesterol<br>oxidase and 4-aminoantipyrine (granulate) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P<br>(human) | Roche Control Serum N and P (human) |
| Performance Characteristics: | | |
| Assay Range | 0 - 18.1 mmol/L (0 - 700 mg/dL)<br>0 - 181 mmol/L (0 - 7000 mg/dL)<br>with post dilution | 0 - 20.7 mmol/L (0 - 800 mg/dL)<br>0 - 207 mmol/L (0 - 8000 mg/dL)<br>with post dilution |
| Precision:<br>Mean (mmol/L) | Level 1 Level 2<br>5.3 6.7<br>(205 mg/dL) (259 mg/dL) | Level 1 Level 2 Level 3<br>5.0 6.3 8.0<br>(94 mg/dL) (242 mg/dL) (309 mg/dL) |
| %CV (within run) | 1.3 1.1 | 1.3 1.0 2.0 |
| %CV (total) | 2.2 2.5 | 1.1 1.2 1.5 |
| Sensitivity | $8.8 X 10^{-2}$ ΔA per mmol/L<br>( $2.3 X 10^{-3}$ ΔA per mg/dL) | $6.4 X 10^{-2}$ ΔA per mmol/L<br>( $1.7 X 10^{-3}$ ΔA per mg/dL) |
| Accuracy: | | |
| Sample size (n) | 214 | 240 |
| Corr. Coefficient (r) | 0.998 | 0.995 |
| Lin. Regression | 0.99x + 0.0 mmol/L vs. COBAS<br>INTEGRA Cholesterol (granulate) | 1.04x + 0.1 mmol/L |
,可以在
# juund
{12}------------------------------------------------
ાં છે. -ﮧ
| | Table 9 - HDL - Cholesterol Application (HDLL) | |
|--|------------------------------------------------|--|
|--|------------------------------------------------|--|
| | COBAS INTEGRA HDL - | | COBAS INTEGRA HDL - | |
|------------------------------|---------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------|----------------------|
| | Cholesterol Application (for use | | Cholesterol Application (for use | |
| | with COBAS INTEGRA Cholesterol | | with COBAS INTEGRA | |
| | Liquid Reagent) | | Cholesterol Granulate Reagent) | |
| Intended Use | quantitative determination HDL<br>cholesterol | | quantitative determination HDL<br>cholesterol | |
| Sample type | serum and plasma | | serum and plasma | |
| Methodology | Phosphotungstic acid pretreatment | | Phosphotungstic acid pretreatment | |
| Reagents | Roche Separating Reagent for HDL -<br>Cholesterol used with COBAS<br>INTEGRA Cholesterol liquid reagent | | Roche Separating Reagent for HDL -<br>- Cholesterol used with COBAS<br>INTEGRA Cholesterol granulate<br>reagent | |
| Calibrator | Roche Calibrator (human) | | Roche Calibrator (human) | |
| Controls | Roche Control Serum N and P<br>(human) | | Roche Control Serum N and P<br>(human) | |
| Performance Characteristics: | | | | |
| Assay Range | 0 - 5.0 mmol/L (0 - 193 mg/dL) | | 0 - 5.0 mmol/L (0 - 193 mg/dL) | |
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 0.20<br>(7.7 mg/dL) | 1.91<br>(73.8mg/dL) | 0.82<br>(31.7 mg/dL) | 1.42<br>(54.9 mg/dL) |
| %CV (within run) | 1.51.3 | 0.26 | 1.2 | 0.85 |
| %CV (total) | 3.0 | 1.6 | 2.7 | 5.5 |
| Sensitivity | $8.8 X 10^{-2}$ ΔA per mmol/L<br>(2.3 X $10^{-3}$ ΔA per mg/dL) | | $6.4 X 10^{-2}$ ΔA per mmol/L<br>(1.7 X $10^{-3}$ AA per mg/dL) | |
| Accuracy: | | | | |
| Sample size (n) | 240 | | 232 | |
| Corr. Coefficient (r) | 0.999 | | 0.998 | |
| Lin. Regression | 0.99x + 0.03 mmol/L vs. COBAS<br>INTEGRA HDL - Cholesterol<br>Application (granulate) | | 0.99x - 0.05 mmol/L | |
043 1
{13}------------------------------------------------
| | COBAS INTEGRA GGTL<br>(Liquid) | COBAS INTEGRA GGT<br>(Granulate) |
|------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of the<br>catalytic activity of GGT | quantitative determination of the<br>catalytic activity of GGT |
| Sample type | serum and plasma | serum and plasma |
| Methodology | kinetic method - Szasz-Persjun | kinetic method - Szasz-Persjun |
| Reagents | R1: Buffer (liquid)<br>R2: L-γ-glutamyl-3-carboxy-4-<br>nitroanilide (liquid) | R1: Buffer (granulate)<br>R2: L-γ-glutamyl-3-carboxy-4-<br>nitroanilide (granulate) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P<br>(human) | Roche Control Serum N and P<br>(human) |
| Performance Characteristics: | | |
| Assay Range | 0 - 600 U/L<br>0 - 6000 U/L with post dilution | 0 - 700 U/L<br>0 - 7000 U/L with post dilution |
| Precision: | Level 1 Level 2 | Level 1 Level 2 |
| Mean (U/L) | 21 428 | 37.9 345 |
| %CV (within run) | 0.83 0.54 | 0.67 0.46 |
| %CV (total) | 2.8 1.5 | 1.2 1.4 |
| Sensitivity | $6.8 X 10^4 ΔA/min per U/L$ | $5.0 X 10^4 ΔA/min per U/L$ |
| Accuracy: | | |
| Sample size (n) | 196 | 238 |
| Corr. Coefficient (r) | 0.999 | 0.998 |
| Lin. Regression | 1.00x - 1.2 U/L vs. COBAS | 1.00x + 0 U/L |
| | INTEGRA GGTL (granulate) | |
# Table 10 - Gamma-Glutamyltransferase (GGTL)
{14}------------------------------------------------
- 14
# Table 11 - Glucose (GLUCL)
| | COBAS INTEGRA Glucose<br>(Liquid) | COBAS INTEGRA Glucose<br>(Granulate) |
|--------------|-------------------------------------------------------|-------------------------------------------------------|
| Intended Use | quantitative determination of<br>glucose | quantitative determination of glucose |
| Sample type | serum, plasma, urine and<br>Cerebrospinal fluid (CSF) | serum, plasma, urine and<br>Cerebrospinal fluid (CSF) |
| Methodology | enzymatic reference method with<br>hexokinase | enzymatic reference method with<br>hexokinase |
| Reagents | R: Enzyme (liquid) | R1: Buffer (granulate)<br>R2: Enzyme (granulate) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P<br>(human) | Roche Control Serum N and P<br>(human) |
## Performance Characteristics for serum and plasma:
| Assay Range | 0 - 40 mmol/L (0-720 mg/dL)<br>0 - 400 mmol/L (0-7200 mg/dL) with<br>post dilution | | 0 - 40 mmol/L (0-720 mg/dL)<br>0 - 400 mmol/L (0-7200 mg/dL) with<br>post dilution | |
|-----------------------|------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------|-------------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 5.3 | 33.2 | 5.6 | 19.7 |
| | (96 mg/dL) | (598 mg/dL) | (101mg/dL) | (355 mg/dL) |
| %CV (within run) | 1.7 | 0.72 | 1.2 | 0.97 |
| %CV (total) | 2.6 | 1.5 | 1.1 | 0.89 |
| Sensitivity | 5.4 X 10-2 ΔA per mmol/L | | 9.3 X 10-2 ΔA per mmol/L | |
| | (3.0 x 10-3 ΔA per mg/dL) | | (5.2 X 10-3 ΔA per mg/dL) | |
| Accuracy: | | | | |
| Sample size (n) | 220 | | 254 | |
| Corr. Coefficient (r) | 0.999 | | 0.997 | |
| Lin. Regression | 1.05x - 0.2 mmol/L vs. COBAS<br>INTEGRA Glucose (granulate) | | 0.98x + 0.1 mmol/L | |
{15}------------------------------------------------
# Table 11 - Glucose - Continued
| Performance Characteristics for urine: | | | | |
|----------------------------------------|------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------|---------------------|
| Assay Range | 0 - 40 mmol/L (0-720 mg/dL)<br>0~ 400 mmol/L (0-7200 mg/dL) with<br>post dilution | | 0 - 16 mmol/L (0-288 mg/dL)<br>0 - 160 mmol/L (0-2880 mg/dL) with<br>post dilution | |
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 1.7<br>(31 mg/dL) | 37.1<br>(668 mg/dL) | 0.27<br>(4.9 mg/dL) | 0.48<br>(8.6 mg/dL) |
| %CV (within run) | 1.7 | 1.8 | 2.0 | 0.99 |
| %CV (total) | 4.3 | 2.9 | | |
| Sensitivity | $5.4 X 10^2$ ΔA per mmol/L<br>(3.0 x $10^{-3}$ ΔA per mg/dL) | | $2.2 X 10^1$ ΔA per mmol/L<br>(1.3 X $10^2$ ΔA per mg/dL) | |
| Accuracy: | | | | |
| Sample size (n) | 120 | Not specified in labeling | | |
| Corr. Coefficient (r) | 0.999 | | | |
| Lin. Regression | 1.01x -0.02 mmol/L vs. COBAS<br>INTEGRA Glucose (granulate) | | | |
| Performance Characteristics for CSF: | | | | |
| Assay Range | 0 - 40 mmol/L (0-720 mg/dL)<br>0 - 400 mmol/L (0-7200 mg/dL) with<br>post dilution | | 0 - 20 mmol/L (0-360 mg/dL)<br>0 - 360 mmol/L (0-3600 mg/dL) with<br>post dilution | |
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 1.7<br>(31 mg/dL) | 3.3<br>(59 mg/dL) | 4.7<br>(85 mg/dL) | 10.3<br>(186 mg/dL) |
| %CV (within run) | 1.6 | 1.8 | 0.57 | 0.23 |
| %CV (total) | 2.3 | 1.9 | | |
| Sensitivity | $5.4 X 10^2$ ΔA per mmol/L<br>(3.0 x $10^{-3}$ ΔA per mg/dL) | | $1.8 X 10^1$ ΔA per mmol/L<br>(1.0 x $10^2$ ΔA per mg/dL) | |
| Accuracy: | | | | |
| Sample size (n) | 212 | Not specified in labeling | | |
| Corr. Coefficient (r) | 0.999 | | | |
| Lin. Regression | 1.02x -0.17 mmol/L vs. COBAS<br>INTEGRA Glucose (granulate) | | | |
{16}------------------------------------------------
, (4)
# Table 12 - Lipase (LIPL)
| | COBAS INTEGRA Lipase<br>(Liquid) | COBAS INTEGRA Lipase<br>(Granulate) |
|------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | quantitative determination of the<br>catalytic activity of lipase | quantitative determination of thecatalytic activity of lipase |
| Sample type | serum and plasma | serum and plasma |
| Methodology | turbidimetric method with triolein | turbidimetric method with triolein |
| Reagents | R: triolein and colipase (liquid) | R: triolein and colipase (granulate) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P<br>(human) | Roche Control Serum N and P<br>(human) |
| Performance Characteristics: | | |
| Assay Range | 0 - 600 U/L<br>0 - 3000 U/L with post dilution | 0 - 700 U/L<br>0 - 3500 U/L with post dilution |
| Precision: | Level 1 Level 2 | Level 1 Level 2 |
| Mean (U/L) | 126 515 | 116 550 |
| %CV (within run) | 1.9 1.3 | 1.7 2.1 |
| %CV (total) | 3.1 2.9 | 4.6 3.7 |
| Sensitivity | 6.4 X 10-5 ΔA/min per U/L | 5.6 X 10-5 ΔA/min per U/L |
| Accuracy: | | |
| Sample size (n) | 198 | 262 |
| Corr. Coefficient (r) | 0.976 | 0.976 |
| Lin. Regression | 0.82x + 16 U/L vs. COBAS<br>INTEGRA Lipase (granulate) | 1.06x - 7 U/L |
1 047
{17}------------------------------------------------
# Table 13 -Urea/BUN (UREAL)
| | COBAS INTEGRA UREA/BUN<br>(Liquid) | COBAS INTEGRA UREA/BUN<br>(Granulate) |
|--------------|---------------------------------------------------------|---------------------------------------------------------|
| Intended Use | quantitative determination of urea/BUN | quantitative determination of urea/BUN |
| Sample type | serum, plasma and urine | serum, plasma and urine |
| Methodology | kinetic test with urease and glutamate<br>dehydrogenase | kinetic test with urease and glutamate<br>dehydrogenase |
| Reagents | R: urease and glutamate dehydrogenase (liquid) | R: urease and glutamate dehydrogenase (granulate) |
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P (human) | Roche Control Serum N and P (human) |
#### Performance Characteristics for serum and plasma:
| Assay Range | 0 - 40 mmol/L (0-12 mg/dL)<br>0 - 400 mmol/L (0-2400 mg/dL) with post<br>dilution | | 0 - 55 mmol/L (0-330 mg/dL)<br>0 - 550 mmol/L (0-3300 mg/dL) with post<br>dilution | |
|-----------------------|-----------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------|---------------------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 4.1<br>(24.6 mg/dL) | 31.0<br>(186 mg/dL) | 6.9<br>(41.4 mg/dL) | 19.9<br>(119 mg/dL) |
| %CV (within run) | 2.3 | 0.89 | 0.85 | 1.0 |
| %CV (total) | 3.9 | 2.8 | 2.0 | 2.3 |
| Sensitivity | $2.2 X 10^{-2}$ ΔA/min per mmol/L<br>( $3.3 X 10^{-3}$ ΔA/min per mg/dL) | | $6.8 X 10^{-3}$ ΔA/min per mmol/L<br>( $1.1 X 10^{-3}$ ΔA/min per mg/dL) | |
| Accuracy: | | | | |
| Sample size (n) | 236 | | 234 | |
| Corr. Coefficient (r) | 0.999 | | 0.999 | |
| Lin. Regression | 1.00x + 0.1 mmol/L vs. COBAS<br>INTEGRA Urea/BUN (granulate) | | 1.01x + 0.30 mmol/L | |
#### Performance Characteristics for urine:
| Assay Range | 0 - 2000 mmol/L (0-12 g/dL)<br>0 - 6000 mmol/L (0-36 g/dL) with post<br>dilution | | 0 - 2200 mmol/L (0-13.2 g/dL)<br>0 - 5500 mmol/L (0-33 g/dL) with post<br>dilution | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------|------------------------------------------------------------------------------------|---------------------------------------|
| Precision:<br>Mean (mmo/L)<br>%CV (within run) | Level 1<br>421<br>(2.53 g/dL)<br>1.3 | Level 2<br>679<br>(4.08 g/dL)<br>1.2 | Level 1<br>73<br>(438 mg/dL)<br>0.99 | Level 2<br>345<br>(2072 mg/dL)<br>0.6 |
| %CV (total)<br>Sensitivity | 1.8<br>1.8<br>2.0 X 10-2 ΔA/min per mmol/L<br>(3.3 X 10-2 ΔA/min per g/dL) | | Not specified in labeling | |
| Accuracy:<br>Sample size (n)<br>Corr. Coefficient (r)<br>Lin. Regression | 120<br>0.999<br>1.0X + 1.3 mmol/L vs. COBAS INTEGRA<br>Urea/BUN (granulate) | | Not specified in labeling | |
{18}------------------------------------------------
Image /page/18/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 12 1997
Ms. Maria Feijoo Regulatory Affairs Associate Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771
Re: K972250 Roche COBAS® INTEGRA Reagent Cassettes & Ancillary Reagents Regulatory Class: II JFJ, CDQ, CDT, CET, CFR, CGX, CHH, LAS, DLJ, Product Code: DLB, JIF, JQB, LFM June 13, 1997 Dated: Received: June 16, 1997
Dear Ms. Feijoo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
{19}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for question…
