(57 days)
No
The document describes a standard in vitro diagnostic reagent system and analyzer with automated features, but there is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on quantitative determination of substances using established chemical and enzymatic methods.
No
The device is described as an "in vitro diagnostic reagent system" intended for "quantitative determination of the ammonia concentration in plasma" and other substances in various bodily fluids. Its purpose is to test samples and provide diagnostic information, not to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the COBAS INTEGRA products contain "an in vitro diagnostic reagent system." The "Device Description" also mentions that "The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing." These phrases directly indicate its diagnostic purpose.
No
The device description clearly outlines a physical analyzer (COBAS INTEGRA Analyzer) that utilizes various measuring principles and handles physical reagent cassettes and samples. The submission is for reagent systems and modifications to existing reagent cassettes, which are physical components used with the analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the COBAS INTEGRA Ammonia, COBAS INTEGRA aAmylase EPS, COBAS INTEGRA Cholesterol, COBAS INTEGRA HDL Cholesterol Application, COBAS INTEGRA Creatinine Enzymatic, COBAS INTEGRA Digitoxin, COBAS INTEGRA Gamma Glutamyltransferase, COBAS INTEGRA Glucose HK Liquid, COBAS INTEGRA Lipase, COBAS INTEGRA Lysergic acid diethylamide, and COBAS INTEGRA Urea/BUN are "in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of..." various substances in biological samples (plasma, serum, urine, cerebrospinal fluid).
The "Device Description" also reinforces this by stating that the COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an "integrated system for in vitro diagnostic testing."
Furthermore, the predicate devices listed are also IVD reagents and systems.
N/A
Intended Use / 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.
Product codes
JIF, JFJ, CHH, N/A, JFY, DKQ, JQB, CFR, CET, N/A, CDQ, DLJ, LAS, CDT, CGX, DLB, LFM
Device Description
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 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. This submission seeks 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, changing them from granulate to liquid form.
The new Reagent Cassettes and ancillary reagents are:
- COBAS INTEGRA Ammonia (NH3)
- COBAS INTEGRA Creatinine Enzymatic (CREAE)
- COBAS INTEGRA Digitoxin (DIGIT)
- Roche TDM OnLine Digitoxin Calibrators
- Roche TDM OnLine Digitoxin Controls
- COBAS INTEGRA Lysergic acid diethylamide (LSD)
The modified Reagent Cassettes are:
- COBAS INTEGRA aAmylase EPS (AMYLL)
- COBAS INTEGRA Cholesterol (CHOLL)
- COBAS INTEGRA HDL - Cholesterol Application (HDLL)
- COBAS INTEGRA Gamma - Glutamyltransferase (GGTL)
- COBAS INTEGRA Glucose HK Liquid (GLUCL)
- COBAS INTEGRA Lipase (LIPL)
- COBAS INTEGRA Urea/BUN (UREAL)
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
Not Found
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)
Clinical and nonclinical studies were performed to demonstrate substantial equivalence. The significant performance characteristics relied upon are summarized in the provided tables.
Table 3 - Ammonia (NH3)
- Sample type: plasma
- Assay Range: 0 - 700 umol/L (0 - 1190 ug/dL) for COBAS INTEGRA Ammonia; 0 - 700 U/L, 0 - 2,800 U/L with postdilution for Roche Reagent for Ammonia.
- Precision:
- COBAS INTEGRA Ammonia: Level 1 (Mean 48.8 umo/L, %CV within run 3.1, %CV total 5.2), Level 2 (Mean 226 umo/L, %CV within run 2.0, %CV total 2.5)
- Roche Reagent for Ammonia: Level 1 2 (%CV within run 5.7, %CV total 8.8), Level 2 (%CV within run 1.9, %CV total 5.9)
- Sensitivity: COBAS INTEGRA Ammonia: 0.76 AA per umol/L; Roche Reagent for Ammonia: 0.0009 AA per umol/L.
- Accuracy: Correlation Coefficient (r) 0.997 (n=164) for COBAS INTEGRA Ammonia, 0.992 for Roche Reagent for Ammonia. Linear Regression 1.03x - 2.8 umol/L vs. Roche Reagent for Ammonia.
Table 4 - Creatinine (CREAE)
- Sample type: serum, plasma and urine
- Performance Characteristics for serum and plasma:
- Assay Range:
- COBAS INTEGRA Creatinine (Enzymatic, PAP): 0 - 2000 µmol/L (0-22.6 mg/dL); 0 - 20000 µmol/L (0-226 mg/dL) with post dilution.
- COBAS INTEGRA Creatinine (Kinetic, Jaffé): 0 - 1300 µmol/L (0-15 mg/dL); 0 - 13000 µmol/L (0-1470 mg/dL) with post dilution.
- Precision:
- COBAS INTEGRA Creatinine (Enzymatic, PAP): Level 1 (Mean 99.4 µmol/L, %CV within run 1.6, %CV total 2.2), Level 2 (Mean 535 µmol/L, %CV within run 0.88, %CV total 1.5).
- COBAS INTEGRA Creatinine (Kinetic, Jaffé): Level 1 (Mean 85.5 µmol/L, %CV within run 1.5, %CV total 1.9), Level 2 (Mean 624 µmol/L, %CV within run 1.1, %CV total 1.5).
- Sensitivity:
- COBAS INTEGRA Creatinine (Enzymatic, PAP): 2.2 X 10-4 ΔA per µmol/L.
- COBAS INTEGRA Creatinine (Kinetic, Jaffé): 8.0 X 10-5 ΔA/min per µmol/L.
- Accuracy:
- COBAS INTEGRA Creatinine (Enzymatic, PAP): Correlation Coefficient (r) 0.999 (n=238). Linear Regression 1.08x - 30.6 µmol/L vs. COBAS INTEGRA Creatinine (Jaffé).
- COBAS INTEGRA Creatinine (Kinetic, Jaffé): Correlation Coefficient (r) 0.999 (n=256). Linear Regression 0.87x - 2 µmol/L.
- Assay Range:
- Performance Characteristics for urine:
- Assay Range:
- COBAS INTEGRA Creatinine (Enzymatic, PAP): 0 - 40 mmol/L (0-450 mg/dL); 0 - 200 mmol/L (0-2260 mg/dL) with post dilution.
- COBAS INTEGRA Creatinine (Kinetic, Jaffé): 0 - 32.5 mmol/L (0-367 mg/dL); 0 - 130 mmol/L (0-1470 mg/dL) with post dilution.
- Precision:
- COBAS INTEGRA Creatinine (Enzymatic, PAP): Level 1 (Mean 4.1 mmol/L, %CV within run 0.88, %CV total 1.1), Level 2 (Mean 14.0 mmol/L, %CV within run 0.87, %CV total 0.93).
- COBAS INTEGRA Creatinine (Kinetic, Jaffé): Level 1 (Mean 5.3 mmol/L, %CV within run 1.5), Level 2 (Mean 19 mmol/L, %CV within run 1.0).
- Sensitivity: COBAS INTEGRA Creatinine (Enzymatic, PAP): 5.7 X 10-3 ΔA per mmol/L.
- Accuracy: COBAS INTEGRA Creatinine (Enzymatic, PAP): Correlation Coefficient (r) 0.999 (n=116). Linear Regression 0.99x -0.28 mmol/L vs. COBAS INTEGRA Creatinine (Jaffé).
- Assay Range:
Table 5 - Digitoxin Reagent, Calibrators, and Controls (DIGIT)
- Sample type: serum and heparinized plasma
- Assay Range: COBAS INTEGRA Digitoxin: 2.0 - 65 ng/mL; Abbott TDx/TDxFLx Digitoxin: 2.0 - 80 ng/mL.
- Precision:
- COBAS INTEGRA Digitoxin: Level 1 (Mean 10.4 ng/mL, %CV within run 6.0, %CV total 7.4), Level 2 (Mean 19.5 ng/mL, %CV within run 3.9, %CV total 4.5), Level 3 (Mean 37.1 ng/mL, %CV within run 3.6, %CV total 3.7).
- Abbott TDx/TDxFLx Digitoxin: Level 1 (Mean 7.5 ng/mL, %CV within run 7.05, %CV total 10.61), Level 2 (Mean 15.0 ng/mL, %CV within run 4.87, %CV total 7.19), Level 3 (Mean 35.0 ng/mL, %CV within run 4.72, %CV total 8.46).
- Sensitivity: COBAS INTEGRA Digitoxin: 2.0 ng/mL; Abbott TDx/TDxFLx Digitoxin: 2.0 ng/mL.
- Accuracy: Correlation Coefficient (r) 0.973 (n=232) for COBAS INTEGRA Digitoxin, 0.967 (n=178) for Abbott TDx/TDxFLx Digitoxin. Linear Regression 0.945x + 1.19 ng/mL vs. Abbott TDx/TDxFLx Digitoxin for COBAS INTEGRA.
Table 6 - Lysergic acid diethylamide (LSD)
- Sample type: urine
- Cutoff: 0.5 ng/mL for both devices.
- Assay Range: 0 - 1 ng/mL for both devices.
- Precision:
- COBAS INTEGRA LSD: Level 1 (Mean O.D. 0.978, %CV within run not specified), Level 2 (Mean O.D. 0.913), Level 3 (Mean O.D. 0.870).
- Roche Abuscreen RIA for LSD: L1 ng/mL (Mean 0.0, %CV within run 0.6), L2 ng/mL (Mean 0.25, %CV within run 1.3), L3 ng/mL (Mean 0.5, %CV within run 1.6), L4 ng/mL (Mean 1.0, %CV within run 1.8).
- Sensitivity: COBAS INTEGRA LSD: 0.10 ng/mL of LSD at > 95% confidence; Roche Abuscreen RIA for LSD: 0.25 ng/mL of LSD at > 99% confidence.
- Accuracy (Positive Samples):
- INTEGRA: 39 positive, 0 negative compared to GC/MS (39 positive, 0 negative) and RIA (39 positive, 0 negative).
- GC/MS: 21 positive compared to RIA (21 positive, 0 negative).
Table 7 - α- Amylase (AMYLL)
- Sample type: serum, plasma and urine
- Performance Characteristics for serum and plasma:
- Assay Range:
- COBAS INTEGRA α - Amylase EPS (Liquid): 0 - 2000 U/L; 0 - 10000 U/L with post dilution.
- COBAS INTEGRA α - Amylase (Granulate): 0 - 2000 U/L; 0 - 20000 U/L with post dilution.
- Precision:
- COBAS INTEGRA α - Amylase EPS (Liquid): Level 1 (Mean 76 U/L, %CV within run 1.6, %CV total 2.3), Level 2 (Mean 498 U/L, %CV within run 1.3, %CV total 2.6).
- COBAS INTEGRA α - Amylase (Granulate): Level 1 (Mean 143 U/L, %CV within run 1.6, %CV total 1.6), Level 2 (Mean 277 U/L, %CV within run 1.1, %CV total 2.0).
- Sensitivity: COBAS INTEGRA α - Amylase EPS (Liquid): 1.9 X 10-4 ΔA/min per U/L; COBAS INTEGRA α - Amylase (Granulate): 1.5 X 10-4 ΔA/min per U/L.
- Accuracy: Correlation Coefficient (r) 0.996 (n=114) for COBAS INTEGRA α - Amylase EPS (Liquid), 0.992 (n=212) for COBAS INTEGRA α - Amylase (Granulate). Linear Regression 0.43x + 4 U/L vs. COBAS INTEGRA α - Amylase (granulate) for Liquid.
- Assay Range:
- Performance Characteristics for urine:
- Assay Range:
- COBAS INTEGRA α - Amylase EPS (Liquid): 0 - 2000 U/L; 0 - 10000 U/L with post dilution.
- COBAS INTEGRA α - Amylase (Granulate): 0 - 2000 U/L; 0 - 20000 U/L with post dilution.
- Precision:
- COBAS INTEGRA α - Amylase EPS (Liquid): Level 1 (Mean 183 U/L, %CV within run 1.3, %CV total 1.7), Level 2 (Mean 603 U/L, %CV within run not specified, %CV total 1.6).
- COBAS INTEGRA α - Amylase (Granulate): Level 1 (Mean 22 U/L, %CV within run 2.5), Level 2 (Mean 302 U/L, %CV within run 0.56).
- Sensitivity: COBAS INTEGRA α - Amylase EPS (Liquid): 1.9 X 10-4 ΔA/min per U/L.
- Accuracy: Correlation Coefficient (r) 0.988 (n=150) for COBAS INTEGRA α - Amylase EPS (Liquid). Linear Regression 0.44x + 0 U/L vs. COBAS INTEGRA α - Amylase (granulate) for Liquid.
- Assay Range:
Table 8 - Cholesterol (CHOLL)
- Sample type: serum and plasma
- Assay Range:
- COBAS INTEGRA Cholesterol (Liquid): 0 - 18.1 mmol/L (0 - 700 mg/dL); 0 - 181 mmol/L (0 - 7000 mg/dL) with post dilution.
- COBAS INTEGRA Cholesterol (Granulate): 0 - 20.7 mmol/L (0 - 800 mg/dL); 0 - 207 mmol/L (0 - 8000 mg/dL) with post dilution.
- Precision:
- COBAS INTEGRA Cholesterol (Liquid): Level 1 (Mean 5.3 mmol/L, %CV within run 1.3, %CV total 2.2), Level 2 (Mean 6.7 mmol/L, %CV within run 1.1, %CV total 2.5).
- COBAS INTEGRA Cholesterol (Granulate): Level 1 (Mean 5.0 mmol/L, %CV within run 1.3, %CV total 1.1), Level 2 (Mean 6.3 mmol/L, %CV within run 1.0, %CV total 1.2), Level 3 (Mean 8.0 mmol/L, %CV within run 2.0, %CV total 1.5).
- Sensitivity: COBAS INTEGRA Cholesterol (Liquid): 8.8 X 10-2 ΔA per mmol/L; COBAS INTEGRA Cholesterol (Granulate): 6.4 X 10-2 ΔA per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.998 (n=214) for COBAS INTEGRA Cholesterol (Liquid), 0.995 (n=240) for COBAS INTEGRA Cholesterol (Granulate). Linear Regression 0.99x + 0.0 mmol/L vs. COBAS INTEGRA Cholesterol (granulate) for Liquid.
Table 9 - HDL - Cholesterol Application (HDLL)
- Sample type: serum and plasma
- Assay Range: 0 - 5.0 mmol/L (0 - 193 mg/dL) for both devices.
- Precision:
- COBAS INTEGRA HDL - Cholesterol Application (for use with COBAS INTEGRA Cholesterol Liquid Reagent): Level 1 (Mean 0.20 mmol/L, %CV within run 1.5, %CV total 3.0), Level 2 (Mean 1.91 mmol/L, %CV within run 0.26, %CV total 1.6).
- COBAS INTEGRA HDL - Cholesterol Application (for use with COBAS INTEGRA Cholesterol Granulate Reagent): Level 1 (Mean 0.82 mmol/L, %CV within run 1.2, %CV total 2.7), Level 2 (Mean 1.42 mmol/L, %CV within run 0.85, %CV total 5.5).
- Sensitivity: COBAS INTEGRA HDL - Cholesterol Application (Liquid): 8.8 X 10-2 ΔA per mmol/L; COBAS INTEGRA HDL - Cholesterol Application (Granulate): 6.4 X 10-2 ΔA per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=240) for COBAS INTEGRA HDL - Cholesterol Application (Liquid), 0.998 (n=232) for COBAS INTEGRA HDL - Cholesterol Application (Granulate). Linear Regression 0.99x + 0.03 mmol/L vs. COBAS INTEGRA HDL - Cholesterol Application (granulate) for Liquid.
Table 10 - Gamma-Glutamyltransferase (GGTL)
- Sample type: serum and plasma
- Assay Range:
- COBAS INTEGRA GGTL (Liquid): 0 - 600 U/L; 0 - 6000 U/L with post dilution.
- COBAS INTEGRA GGT (Granulate): 0 - 700 U/L; 0 - 7000 U/L with post dilution.
- Precision:
- COBAS INTEGRA GGTL (Liquid): Level 1 (Mean 21 U/L, %CV within run 0.83, %CV total 2.8), Level 2 (Mean 428 U/L, %CV within run 0.54, %CV total 1.5).
- COBAS INTEGRA GGT (Granulate): Level 1 (Mean 37.9 U/L, %CV within run 0.67, %CV total 1.2), Level 2 (Mean 345 U/L, %CV within run 0.46, %CV total 1.4).
- Sensitivity: COBAS INTEGRA GGTL (Liquid): 6.8 X 10^4 ΔA/min per U/L; COBAS INTEGRA GGT (Granulate): 5.0 X 10^4 ΔA/min per U/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=196) for COBAS INTEGRA GGTL (Liquid), 0.998 (n=238) for COBAS INTEGRA GGT (Granulate). Linear Regression 1.00x - 1.2 U/L vs. COBAS INTEGRA GGTL (granulate) for Liquid.
Table 11 - Glucose (GLUCL)
- Sample type: serum, plasma, urine and Cerebrospinal fluid (CSF)
- Performance Characteristics for serum and plasma:
- Assay Range: 0 - 40 mmol/L (0-720 mg/dL); 0 - 400 mmol/L (0-7200 mg/dL) with post dilution for both devices.
- Precision:
- COBAS INTEGRA Glucose (Liquid): Level 1 (Mean 5.3 mmol/L, %CV within run 1.7, %CV total 2.6), Level 2 (Mean 33.2 mmol/L, %CV within run 0.72, %CV total 1.5).
- COBAS INTEGRA Glucose (Granulate): Level 1 (Mean 5.6 mmol/L, %CV within run 1.2, %CV total 1.1), Level 2 (Mean 19.7 mmol/L, %CV within run 0.97, %CV total 0.89).
- Sensitivity: COBAS INTEGRA Glucose (Liquid): 5.4 X 10-2 ΔA per mmol/L; COBAS INTEGRA Glucose (Granulate): 9.3 X 10-2 ΔA per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=220) for COBAS INTEGRA Glucose (Liquid), 0.997 (n=254) for COBAS INTEGRA Glucose (Granulate). Linear Regression 1.05x - 0.2 mmol/L vs. COBAS INTEGRA Glucose (granulate) for Liquid.
- Performance Characteristics for urine:
- Assay Range:
- COBAS INTEGRA Glucose (Liquid): 0 - 40 mmol/L (0-720 mg/dL); 0~ 400 mmol/L (0-7200 mg/dL) with post dilution.
- COBAS INTEGRA Glucose (Granulate): 0 - 16 mmol/L (0-288 mg/dL); 0 - 160 mmol/L (0-2880 mg/dL) with post dilution.
- Precision:
- COBAS INTEGRA Glucose (Liquid): Level 1 (Mean 1.7 mmol/L, %CV within run 1.7, %CV total 4.3), Level 2 (Mean 37.1 mmol/L, %CV within run 1.8, %CV total 2.9).
- COBAS INTEGRA Glucose (Granulate): Level 1 (Mean 0.27 mmol/L, %CV within run 2.0), Level 2 (Mean 0.48 mmol/L, %CV within run 0.99).
- Sensitivity: COBAS INTEGRA Glucose (Liquid): 5.4 X 10^2 ΔA per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=120) for COBAS INTEGRA Glucose (Liquid). Linear Regression 1.01x -0.02 mmol/L vs. COBAS INTEGRA Glucose (granulate) for Liquid.
- Assay Range:
- Performance Characteristics for CSF:
- Assay Range:
- COBAS INTEGRA Glucose (Liquid): 0 - 40 mmol/L (0-720 mg/dL); 0 - 400 mmol/L (0-7200 mg/dL) with post dilution.
- COBAS INTEGRA Glucose (Granulate): 0 - 20 mmol/L (0-360 mg/dL); 0 - 360 mmol/L (0-3600 mg/dL) with post dilution.
- Precision:
- COBAS INTEGRA Glucose (Liquid): Level 1 (Mean 1.7 mmol/L, %CV within run 1.6, %CV total 2.3), Level 2 (Mean 3.3 mmol/L, %CV within run 1.8, %CV total 1.9).
- COBAS INTEGRA Glucose (Granulate): Level 1 (Mean 4.7 mmol/L, %CV within run 0.57), Level 2 (Mean 10.3 mmol/L, %CV within run 0.23).
- Sensitivity: COBAS INTEGRA Glucose (Liquid): 5.4 X 10^2 ΔA per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=212) for COBAS INTEGRA Glucose (Liquid). Linear Regression 1.02x -0.17 mmol/L vs. COBAS INTEGRA Glucose (granulate) for Liquid.
- Assay Range:
Table 12 - Lipase (LIPL)
- Sample type: serum and plasma
- Assay Range:
- COBAS INTEGRA Lipase (Liquid): 0 - 600 U/L; 0 - 3000 U/L with post dilution.
- COBAS INTEGRA Lipase (Granulate): 0 - 700 U/L; 0 - 3500 U/L with post dilution.
- Precision:
- COBAS INTEGRA Lipase (Liquid): Level 1 (Mean 126 U/L, %CV within run 1.9, %CV total 3.1), Level 2 (Mean 515 U/L, %CV within run 1.3, %CV total 2.9).
- COBAS INTEGRA Lipase (Granulate): Level 1 (Mean 116 U/L, %CV within run 1.7, %CV total 4.6), Level 2 (Mean 550 U/L, %CV within run 2.1, %CV total 3.7).
- Sensitivity: COBAS INTEGRA Lipase (Liquid): 6.4 X 10-5 ΔA/min per U/L; COBAS INTEGRA Lipase (Granulate): 5.6 X 10-5 ΔA/min per U/L.
- Accuracy: Correlation Coefficient (r) 0.976 (n=198) for COBAS INTEGRA Lipase (Liquid), 0.976 (n=262) for COBAS INTEGRA Lipase (Granulate). Linear Regression 0.82x + 16 U/L vs. COBAS INTEGRA Lipase (granulate) for Liquid.
Table 13 -Urea/BUN (UREAL)
- Sample type: serum, plasma and urine
- Performance Characteristics for serum and plasma:
- Assay Range:
- COBAS INTEGRA UREA/BUN (Liquid): 0 - 40 mmol/L (0-12 mg/dL); 0 - 400 mmol/L (0-2400 mg/dL) with post dilution.
- COBAS INTEGRA UREA/BUN (Granulate): 0 - 55 mmol/L (0-330 mg/dL); 0 - 550 mmol/L (0-3300 mg/dL) with post dilution.
- Precision:
- COBAS INTEGRA UREA/BUN (Liquid): Level 1 (Mean 4.1 mmol/L, %CV within run 2.3, %CV total 3.9), Level 2 (Mean 31.0 mmol/L, %CV within run 0.89, %CV total 2.8).
- COBAS INTEGRA UREA/BUN (Granulate): Level 1 (Mean 6.9 mmol/L, %CV within run 0.85, %CV total 2.0), Level 2 (Mean 19.9 mmol/L, %CV within run 1.0, %CV total 2.3).
- Sensitivity: COBAS INTEGRA UREA/BUN (Liquid): 2.2 X 10-2 ΔA/min per mmol/L; COBAS INTEGRA UREA/BUN (Granulate): 6.8 X 10-3 ΔA/min per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=236) for COBAS INTEGRA UREA/BUN (Liquid), 0.999 (n=234) for COBAS INTEGRA UREA/BUN (Granulate). Linear Regression 1.00x + 0.1 mmol/L vs. COBAS INTEGRA Urea/BUN (granulate) for Liquid.
- Assay Range:
- Performance Characteristics for urine:
- Assay Range:
- COBAS INTEGRA UREA/BUN (Liquid): 0 - 2000 mmol/L (0-12 g/dL); 0 - 6000 mmol/L (0-36 g/dL) with post dilution.
- COBAS INTEGRA UREA/BUN (Granulate): 0 - 2200 mmol/L (0-13.2 g/dL); 0 - 5500 mmol/L (0-33 g/dL) with post dilution.
- Precision:
- COBAS INTEGRA UREA/BUN (Liquid): Level 1 (Mean 421 mmol/L, %CV within run 1.3, %CV total 1.8), Level 2 (Mean 679 mmol/L, %CV within run 1.2, %CV total 1.8).
- Sensitivity: COBAS INTEGRA UREA/BUN (Liquid): 2.0 X 10-2 ΔA/min per mmol/L.
- Accuracy: Correlation Coefficient (r) 0.999 (n=120) for COBAS INTEGRA UREA/BUN (Liquid). Linear Regression 1.0X + 1.3 mmol/L vs. COBAS INTEGRA Urea/BUN (granulate) for Liquid.
- Assay Range:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics are included within the "Summary of Performance Studies" under the "Precision", "Sensitivity", and "Accuracy" sections for each test. For example, "Corr. Coefficient (r)" (correlation coefficient), "Lin. Regression" (linear regression), and "%CV" (coefficient of variation) are provided.
Predicate Device(s)
Reference Device(s)
K954992, K961824, K963292, K964457
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1070 Amylase test system.
(a)
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).(b)
Classification. Class II.
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, | ||
| Enzymatic method | JIF | 862.1065 | |
| αAmylase EPS | Amylase test system, | ||
| Catalytic method | JFJ | 862.1070 | |
| Cholesterol | Cholesterol test system, | ||
| Enzymatic esterase - oxidase | |||
| method | CHH | 862.1175 | |
| HDL-Cholesterol | Lipoprotein test system, | ||
| Phosphotungstic acid method | N/A | 862.1475 | |
| Creatinine | Creatinine test system, | ||
| Enzymatic method | JFY | 862.1225 | |
| Digitoxin | Digitoxin test system, | ||
| Kinetic interaction of | |||
| microparticles in solution method | DKQ | 862.3300 | |
| Gamma-Glutamyltransferase (GGT) | Gamma-glutamyl transpeptidase and isoenzymes test system, | ||
| Kinetic method | JQB | 862.1360 | |
| Glucose HK | Glucose test system, | ||
| Enzymatic method | CFR | 862.1345 | |
| Lipase | Lipase test system, | ||
| Turbidimetric method | CET | 862.1465 | |
| Lysergic acid diethylamide (LSD) | Lysergic acid diethylamide (LSD) test system, | ||
| Kinetic interaction of | |||
| microparticles in solution method | N/A | 862.3580 | |
| Urea | Urea nitrogen test system, | ||
| Kinetic urease method | CDQ | 862.1770 | |
| Roche TDM OnLine... | |||
| Digitoxin Calibrators | Clinical toxicology calibrator, | ||
| Drug specific | DLJ | 862.3200 | |
| Digitoxin Controls | Clinical toxicology control | ||
| material, | |||
| Drug specific | LAS | 862.3280 |
| able
œ
| 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
substantial
equivalence |
|----------------------------------|-------------------------------------------------------------|----------|---------------------------------------|
| COBAS INTEGRA... | | | |
| Ammonia | Roche Reagent for Ammonia | K913124 | 8/12/91 |
| αAmylase EPS (Liquid) | COBAS INTEGRA αAmylase (Granulate,
CL-PNP-G, method) | K951595 | 9/8/95 |
| Cholesterol (Liquid) | COBAS INTEGRA Cholesterol (Granulate) | K951595 | 9/8/95 |
| HDL - Cholesterol (Liquid) | COBAS INTEGRAHDL - Cholesterol
(Granulate) | K951595 | 9/8/95 |
| Creatinine (Enzymatic) | COBAS INTEGRA Creatinine (Kinetic
Jaffe) | K951595 | 9/8/95 |
| Digitoxin | Abbott Diagnostics, TDX / TDX Flex
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
Digitoxin Calibrators | K842280 | 8/16/84 |
| Digitoxin Controls | Abbott Diagnostics, TDX / TDX Flex
Digitoxin Controls | K842280 | 8/16/84 |
| 11
C | abl
ા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
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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
(Enzymatic, PAP) | COBAS INTEGRA Creatinine
(Kinetic, Jaffé) |
|--------------|----------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended Use | quantitative determination of the catalytic
activity of a amylase | quantitative determination of the catalytic
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)
R2: Substrate (liquid) | R1: Alkaline buffer (liquid)
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)
0 - 20000 µmol/L (0-226 mg/dL) with post dilution | 0 - 1300 µmol/L (0-15 mg/dL)
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
(1.1mg/dL) | 535
(6.0 mg/dL) | 85.5
(0.97mg/dL) | 624
(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
(1.9 X 10-4 ΔA per mg/dL) | | 8.0 X 10-5 ΔA/min per µmol/L
(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
INTEGRA Creatinine (Jaffé) | | 0.87x - 2 µmol/L | |
Performance Characteristics for urine:
| Assay Range | 0 - 40 mmol/L (0-450 mg/dL)
0 - 200 mmol/L (0-2260 mg/dL) with post
dilution | 0 - 32.5 mmol/L (0-367 mg/dL)
0 - 130 mmol/L (0-1470 mg/dL) with post
dilution | | |
|-----------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------|-------------------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmo/L) | 4.1
(46.7 mg/dL) | 14.0
(159 mg/dL) | 5.3
(60 mg/dL) | 19
(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
( $5.1 X 10^{-2}$ 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
INTEGRA Creatinine (Jaffé) | | | |
8
Lin. Regression
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1.060 + 0.729 ng/mL
Table 5 - Digitoxin Reagent, Calibrators, and Controls (DIGIT)
| COBAS INTEGRA Digitoxin &
Roche - TDM OnLine Digitoxin
Calibrators & Controls | | | Abbott TDx/TDxFLx Digitoxin
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
solution (KIMS) | | fluorescence polarization (FPIA) | | | |
| Reagents | R1: Anti-digitoxin monoclonal antibody
(mouse) in buffer (liquid)
R2: Conjugated digitoxin derivative
microparticles in buffer (liquid) | | R1: Digitoxin Antiserum (Rabbit) in
buffer
R2: Digitoxin Fluorescein tracer in buffer | | | |
| Calibrator Levels
(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
(ng/mL)
(in human serum) | Level 1
12.0 - 18.0 | Level 2
24.0 - 36.0 | Level 3
36.0 - 54.0 | Level 1
5.4- 9.6 | Level 2
12.0- 18.0 | Level 3
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:
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 | |
| metabolites | detection of LSD and its metabolites | |
| Sample type | urine | urine |
| Methodology | kinetic interaction of microparticles in | |
| solution (KIMS) | competitive binding to antibody of ¹²⁵I- | |
| radiolabeled antigen and unlabeled | ||
| antigen | ||
| Cutoff | 0.5 ng/mL | 0.5 ng/mL |
| Reagents | R1: Buffer | |
| R2: conjugated LSD derivative | ||
| microparticles in buffer | ||
| R3: LSD polyclonal antibody (goat) in | ||
| buffer | R1: LSD polyclonal (rabbit) antibody in | |
| buffer | ||
| R2: ¹²⁵I-LSD in buffer | ||
| R3: Anti-rabbit immunoglobulin serum | ||
| (goat) in buffer | ||
| Calibrator | Roche Abuscreen Calibration Standard | Roche Abuscreen Calibration Standard |
| Controls | Roche Abuscreen Reference Controls | |
| and Calibrator | Roche Abuscreen Reference Controls | |
| and Calibrator |
Performance Characteristics:
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| Assay Range | 0 - 1 ng/mL | 0 - 1 ng/mL | ||||||
|---|---|---|---|---|---|---|---|---|
| Precision: | Level 1 | Level 2 | Level 3 | L1 | ||||
| ng/mL | L2 | |||||||
| ng/mL | L3 | |||||||
| ng/mL | L4 | |||||||
| 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 | |||
| + | ||||||||
| 39 |
0 | 39
0 | 39
0 | + | 21 | | 21
0 | |
10
Table 7 - α- Amylase (AMYLL)
| | COBAS INTEGRA α - Amylase
EPS (Liquid) | COBAS INTEGRA α - Amylase
(Granulate) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of the
catalytic activity of α amylase | quantitative determination of the
catalytic activity of α amylase |
| Sample type | serum, plasma and urine | serum, plasma and urine |
| Methodology | enzymatic colorimetric method
using the substrate 4,6-ethylidene
-p-nitrophenyl-α,D-
maltoheptaoside | enzymatic colorimetric method with 2-
chloro -4-nitrophenyl-β-D-
maltoheptaoside |
| Reagents | R1: Enzyme (liquid)
R2: Substrate (liquid) | R1: Enzyme (granulate)
R2: Substrate (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 - 2000 U/L
0 - 10000 U/L with post dilution | 0 - 2000 U/L
0 - 20000 U/L with post dilution |
| Precision:
Mean (U/L) | Level 1
76 | Level 2
498 |
| | Level 1
143 | Level 2
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
0 - 10000 U/L with post dilution | | 0 - 2000 U/L
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
INTEGRA α - Amylase (granulate) | | | |
11
Table 8 - Cholesterol (CHOLL)
| | COBAS INTEGRA Cholesterol
(Liquid) | COBAS INTEGRA Cholesterol
(Granulate) |
|------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of total
cholesterol & HDL cholesterol | quantitative determination of total
cholesterol & HDL cholesterol |
| Sample type | serum and plasma | serum and plasma |
| Methodology | enzymatic, colorimetric method
using cholesterol esterase,
cholesterol oxidase and 4-
aminoantipyrine | enzymatic, colorimetric method using
cholesterol esterase, cholesterol oxidase
and 4-aminoantipyrine |
| Reagents | R: Cholesterol esterase, cholesterol
oxidase and 4-aminoantipyrine
(liquid) | R: Cholesterol esterase, cholesterol
oxidase and 4-aminoantipyrine (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: | | |
| Assay Range | 0 - 18.1 mmol/L (0 - 700 mg/dL)
0 - 181 mmol/L (0 - 7000 mg/dL)
with post dilution | 0 - 20.7 mmol/L (0 - 800 mg/dL)
0 - 207 mmol/L (0 - 8000 mg/dL)
with post dilution |
| Precision:
Mean (mmol/L) | Level 1 Level 2
5.3 6.7
(205 mg/dL) (259 mg/dL) | Level 1 Level 2 Level 3
5.0 6.3 8.0
(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
( $2.3 X 10^{-3}$ ΔA per mg/dL) | $6.4 X 10^{-2}$ ΔA per mmol/L
( $1.7 X 10^{-3}$ 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
INTEGRA Cholesterol (granulate) | 1.04x + 0.1 mmol/L |
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| 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 | |||
| cholesterol | quantitative determination HDL | |||
| cholesterol | ||||
| Sample type | serum and plasma | serum and plasma | ||
| Methodology | Phosphotungstic acid pretreatment | Phosphotungstic acid pretreatment | ||
| Reagents | Roche Separating Reagent for HDL - | |||
| Cholesterol used with COBAS | ||||
| INTEGRA Cholesterol liquid reagent | Roche Separating Reagent for HDL - |
- Cholesterol used with COBAS
INTEGRA Cholesterol granulate
reagent | |
| Calibrator | Roche Calibrator (human) | | Roche Calibrator (human) | |
| Controls | Roche Control Serum N and P
(human) | | Roche Control Serum N and P
(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
(7.7 mg/dL) | 1.91
(73.8mg/dL) | 0.82
(31.7 mg/dL) | 1.42
(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
(2.3 X $10^{-3}$ ΔA per mg/dL) | | $6.4 X 10^{-2}$ ΔA per mmol/L
(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
INTEGRA HDL - Cholesterol
Application (granulate) | | 0.99x - 0.05 mmol/L | |
043 1
13
| | COBAS INTEGRA GGTL
(Liquid) | COBAS INTEGRA GGT
(Granulate) |
|------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of the
catalytic activity of GGT | quantitative determination of the
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)
R2: L-γ-glutamyl-3-carboxy-4-
nitroanilide (liquid) | R1: Buffer (granulate)
R2: L-γ-glutamyl-3-carboxy-4-
nitroanilide (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: | | |
| Assay Range | 0 - 600 U/L
0 - 6000 U/L with post dilution | 0 - 700 U/L
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
(Liquid) | COBAS INTEGRA Glucose
(Granulate) |
|--------------|-------------------------------------------------------|-------------------------------------------------------|
| Intended Use | quantitative determination of
glucose | quantitative determination of glucose |
| Sample type | serum, plasma, urine and
Cerebrospinal fluid (CSF) | serum, plasma, urine and
Cerebrospinal fluid (CSF) |
| Methodology | enzymatic reference method with
hexokinase | enzymatic reference method with
hexokinase |
| Reagents | R: Enzyme (liquid) | R1: Buffer (granulate)
R2: Enzyme (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 (0-720 mg/dL)
0 - 400 mmol/L (0-7200 mg/dL) with
post dilution | | 0 - 40 mmol/L (0-720 mg/dL)
0 - 400 mmol/L (0-7200 mg/dL) with
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
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) | |||
| 0~ 400 mmol/L (0-7200 mg/dL) with | ||||
| post dilution | 0 - 16 mmol/L (0-288 mg/dL) | |||
| 0 - 160 mmol/L (0-2880 mg/dL) with | ||||
| post dilution | ||||
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 1.7 | |||
| (31 mg/dL) | 37.1 | |||
| (668 mg/dL) | 0.27 | |||
| (4.9 mg/dL) | 0.48 | |||
| (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 | |||
| (3.0 x $10^{-3}$ ΔA per mg/dL) | $2.2 X 10^1$ ΔA per mmol/L | |||
| (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 | |||
| INTEGRA Glucose (granulate) | ||||
| Performance Characteristics for CSF: | ||||
| Assay Range | 0 - 40 mmol/L (0-720 mg/dL) | |||
| 0 - 400 mmol/L (0-7200 mg/dL) with | ||||
| post dilution | 0 - 20 mmol/L (0-360 mg/dL) | |||
| 0 - 360 mmol/L (0-3600 mg/dL) with | ||||
| post dilution | ||||
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 1.7 | |||
| (31 mg/dL) | 3.3 | |||
| (59 mg/dL) | 4.7 | |||
| (85 mg/dL) | 10.3 | |||
| (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 | |||
| (3.0 x $10^{-3}$ ΔA per mg/dL) | $1.8 X 10^1$ ΔA per mmol/L | |||
| (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 | |||
| INTEGRA Glucose (granulate) |
16
, (4)
Table 12 - Lipase (LIPL)
| | COBAS INTEGRA Lipase
(Liquid) | COBAS INTEGRA Lipase
(Granulate) |
|------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | quantitative determination of the
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
(human) | Roche Control Serum N and P
(human) |
| Performance Characteristics: | | |
| Assay Range | 0 - 600 U/L
0 - 3000 U/L with post dilution | 0 - 700 U/L
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
INTEGRA Lipase (granulate) | 1.06x - 7 U/L |
1 047
17
Table 13 -Urea/BUN (UREAL)
| | COBAS INTEGRA UREA/BUN
(Liquid) | COBAS INTEGRA UREA/BUN
(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
dehydrogenase | kinetic test with urease and glutamate
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)
0 - 400 mmol/L (0-2400 mg/dL) with post
dilution | | 0 - 55 mmol/L (0-330 mg/dL)
0 - 550 mmol/L (0-3300 mg/dL) with post
dilution | |
|-----------------------|-----------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------|---------------------|
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (mmol/L) | 4.1
(24.6 mg/dL) | 31.0
(186 mg/dL) | 6.9
(41.4 mg/dL) | 19.9
(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
( $3.3 X 10^{-3}$ ΔA/min per mg/dL) | | $6.8 X 10^{-3}$ ΔA/min per mmol/L
( $1.1 X 10^{-3}$ 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
INTEGRA Urea/BUN (granulate) | | 1.01x + 0.30 mmol/L | |
Performance Characteristics for urine:
| Assay Range | 0 - 2000 mmol/L (0-12 g/dL)
0 - 6000 mmol/L (0-36 g/dL) with post
dilution | | 0 - 2200 mmol/L (0-13.2 g/dL)
0 - 5500 mmol/L (0-33 g/dL) with post
dilution | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------|------------------------------------------------------------------------------------|---------------------------------------|
| Precision:
Mean (mmo/L)
%CV (within run) | Level 1
421
(2.53 g/dL)
1.3 | Level 2
679
(4.08 g/dL)
1.2 | Level 1
73
(438 mg/dL)
0.99 | Level 2
345
(2072 mg/dL)
0.6 |
| %CV (total)
Sensitivity | 1.8
1.8
2.0 X 10-2 ΔA/min per mmol/L
(3.3 X 10-2 ΔA/min per g/dL) | | Not specified in labeling | |
| Accuracy:
Sample size (n)
Corr. Coefficient (r)
Lin. Regression | 120
0.999
1.0X + 1.3 mmol/L vs. COBAS INTEGRA
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 questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
20
Page 1 of 4
510(k) Number (if known)
Device Name: Roche COBAS® INTEGRA Reagent Cassettes for:
- l. Ammonia
-
- xAmylase EPS (liquid reagent)
-
- Cholesterol (liquid reagent)
-
- HDL Cholesterol Application
-
- Creatinine (enzymatic)
-
- Digitoxin
-
- Gamma-Glutamyltransferaste (liquid reagent)
-
- Glucose HK (liquid reagent)
-
- Lipase (liquid reagent)
-
- Lysergic acid diethylamide (LSD)
-
- Urea (liquid reagent)
Ancillary Reagents:
-
- Roche TDM OnLine Digitoxin Calibrators
-
- Roche TDM OnLine Digitoxin Controls
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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
ision Sign-Off)
- of Clinical Laboratory Devices
Educator
OR
21
Page 2 of 4
510(k) Number (if known)
Indications for Use (continued):
- COBAS INTEGRA aAmylase EPS (AMYLL): 2. 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): 3. દ્ધ 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): 4. 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.
- ડ. 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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
22
Page 3 of 4
510(k) Number (if known)
Indications for Use (continued):
- COBAS INTEGRA Digitoxin (DIGIT): 6. 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): 7. 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): 8.
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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
23
Page 4 of of a イ
510(k) Number (if known)
Indications for Use (continued):
- COBAS INTEGRA Lysergic acid diethylamide (LSD) 10. 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): 11. 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: 12. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR