(71 days)
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
Through this submission, it is the intention of Roche to gain clearance of an additional 4 COBAS Reagent Cassettes and 6 ancillary reagents. These are the COBAS INTEGRA Cassette for Antithrombin III, COBAS INTEGRA Cassette for Ferritin, COBAS INTEGRA Cassette for Myoglobin, COBAS INTEGRA Cassette for Rheumatoid Factors, Roche Plasmachrom Calibrator, Roche Plasmachrom N & P Controls, Roche FERR T Standard, Roche FERR/MYO T Control, Roche MYOT Standard, and Roche RF Standard II. The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYOT Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Calcium. The performance of the COBAS INTEGRA Reagent Cassette for Calcium has been improved due to the use of new instrument parameters.
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
The provided text describes several COBAS INTEGRA Reagent Cassettes and ancillary reagents. Each product has its own performance characteristics detailed in separate tables comparing it to a predicate device. I will break down the acceptance criteria and study information for each of the primary assay cassettes.
General Information Applicable to All Devices:
- Data Provenance: Not explicitly stated, but clinical and non-clinical studies are mentioned. It is implicitly retrospective as it compares performance to predicate devices and existing methodologies.
- Number of experts used to establish ground truth & qualifications: Not specified.
- Adjudication method: Not specified.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as these are diagnostic assays, not image-based AI systems involving human readers.
- Standalone (algorithm only) performance: This is the core of the evaluation for these devices, as they are automated diagnostic assays.
- Type of ground truth: For accuracy, the ground truth is established by correlation to a legally marketed predicate device or a clinical method (e.g., enzyme immunoassay, radioimmunoassay).
1. COBAS INTEGRA Cassette for Antithrombin III
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Berichrom AT III) | Reported Device Performance (COBAS INTEGRA AT III) |
|---|---|---|
| Assay Range | 0-140% | 0-150% |
| Precision (Day-to-day) | Normal plasma: 1.0-2.5% | 4.1% at 51.9% |
| Pathological plasma: 1.5-3.0% | 2.8% at 105.7% | |
| Accuracy (R-value) | > 0.95 vs. Berichrom Reagent | R = 0.973 vs. Berichrom Reagent |
| Sensitivity (Analytical) | Not specified in labeling | 1.6 X 10⁻³ ΔA/min per % change in AT III activity |
Study Details:
- Sample size for test set: N = 200 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
2. COBAS INTEGRA Cassette for Ferritin
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Behring N Latex Ferritin) | Reported Device Performance (COBAS INTEGRA Ferritin) |
|---|---|---|
| Assay Range | 5-320 ug/L | 0-300 ug/L (0-3000 ug/L with postdilution) |
| Precision (Within-run) | 3.8% at 5 ug/L1.5% at 15 ug/L | 9.9 % at 19 ug/L1.2 % at 260 ug/L |
| Accuracy (Regression) | y = 0.80x + 2.9 ug/L vs.behring N Latex Ferritin; < 10 ug/L (vs. radioimmunoassay) | y = 1.01x - 0.37 ug/L vs. enzyme immunoassay |
| Sensitivity (Analytical) | 25 ug/L (vs. radioimmunoassay) | 1.3% at 30 ug/L1.5% at 50 ug/L0.9% at 200 ug/L (These are precision measurements, not analytical sensitivity values as typically described) |
Study Details:
- Sample size for test set: N = 188 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
3. COBAS INTEGRA Cassette for Myoglobin
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Behring N Latex Myoglobin) | Reported Device Performance (COBAS INTEGRA Myoglobin) |
|---|---|---|
| Assay Range | 25-400 ug/L | 0-500 ug/L (0-5000 IU/mL with postdilution) |
| Precision (Day-to-day) | 4.8% at 85 ug/L4.2% at 160 ug/L5.0% at 310 ug/L | 1.4% at 46 ug/L0.6% at 312 ug/L |
| Accuracy (Regression) | y = 0.95X - 4.33 vs. radioimmunoassay (for predicate)N = 117 (for predicate) | y = 0.91x + 15 ug/L vs. Behring N Latex Myoglobin |
| Sensitivity (Analytical) | 3 ug/L (This value appears to be the predicate's sensitivity, not specific acceptance criterion). | Not explicitly stated in a comparable format for the device. |
Study Details:
- Sample size for test set: N = 230 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
4. COBAS INTEGRA Cassette for Rheumatoid Factors
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Behring N Latex RF) | Reported Device Performance (COBAS INTEGRA Rheumatoid Factors) |
|---|---|---|
| Assay Range | 10-600 IU/mL | 10-120 IU/mL (10-600 IU/mL with postdilution) |
| Precision (Day-to-day) | 9.3% at 92 IU/mL6.2% at 155 IU/mL6.6% at 306 IU/mL | 8.0% at 32 IU/mL5.0% at 125 IU/mL |
| Accuracy (Regression) | y = 0.99 x - 20 IU/mL vs. enzyme immunoassay (for predicate)N = 72 (for predicate) | y = 0.70x + 12 IU/mL vs. Behring N Latex RF Reagent |
| Sensitivity (Analytical) | 10 IU/mL | 10 IU/mL |
Study Details:
- Sample size for test set: N = 244 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
5. COBAS INTEGRA Cassette for Calcium (Modified)
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Original COBAS INTEGRA Calcium or Boehringer Mannheim Calcium on Hitachi 911) | Reported Device Performance (COBAS INTEGRA Calcium - Modified) |
|---|---|---|
| Assay Range (Serum/Plasma) | Original: 0-20 mg/dLPredicate: 0-15 mg/dL (0-24.9 w/postdilution) | 0-20 mg/dL (0-140 mg/dL with postdilution) |
| Assay Range (Urine) | Original: 0-100 mg/dLPredicate: 0-15 mg/dL (0-60 mg/dL w/postdilution) | 0-28 mg/dL (0-140 mg/dL with postdilution) |
| Precision (Total) Serum/Plasma | Original: 2.1 % at 7.9 mg/dL; 1.8 % at 10.2 mg/dLPredicate: 1.6 % at 8.9 mg/dL; 1.2 % at 9.7 mg/dL; 1.3% at 12.5 mg/dL | 3.5% at 9.2 mg/dL3.1% at 13.6 mg/dL |
| Precision (Total) Urine | Original: 2.8% at 3.9 mg/dL; 0.77% at 18 mg/dLPredicate: 2.2% at 2.9 mg/dL; 1.7% at 7.8 mg/dL; 1.4% at 36.7 mg/dL | 0.91% at 5.6 mg/dL1.1% at 23.7 mg/dL |
| Accuracy (R-value) | Original: R = 0.960 vs. BM Hitachi 911Predicate: R = 0.997 vs. BM Hitachi 717 | R = 0.987 vs. BM Hitachi 911 |
| Sensitivity (Analytical) | Original: 3.2 X 10⁻² AA per mg/dLPredicate: Not specified in labeling | 4.0 X 10⁻² AA per mg/dL of calcium |
Study Details:
- Sample size for test set: N = 196 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
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Image /page/0/Picture/1 description: The image shows the logo for Roche Diagnostic Systems. The logo consists of the Roche symbol on the left, followed by the text "Roche Diagnostic Systems" in bold, sans-serif font. The Roche symbol is a stylized graphic, and the text is aligned horizontally.
A Member of the Roche Group
OCT 31 1988
Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Branchourg, New Jersey 08876-1760
Direct Dial Fax
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.
I. Identification of 510(k) Sponsor:
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 August 20, 1996
Contact: Andrea Casper Sr. Manager Regulatory and Clinical Affairs Phone: (908) 253-7332 Fax: (908) 253-7547
II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Product Name | ClassificationName | RegulatoryClass | CFRClassificationNumber | PredicateProductName | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|---|---|---|
| Chemistry Panel | ||||||
| COBAS INTEGRACalcium(modification) | Calcium testsystem | Class II | 862.1145 | COBAS INTEGRACalciumBoehringerMannheimCalcium Reagent | 9/5/951/23/85 | K951595K850281 |
| Immunology Panel | ||||||
| COBAS INTEGRAAntithrombin III | Antithrombin IIIassay | Class II | 866.7060 | BerichromAntithrombin IIIReagent | 4/19/94 | K933125 |
Table 1
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| COBAS INTEGRAFerritin | Ferritinimmunologicaltest system | Class II | 866.5340 | Behring N LatexFerritin Reagent | 3/27/95 | K950707 |
|---|---|---|---|---|---|---|
| COBAS INTEGRAMyoglobin | Myoglobinimmunologicaltest system | Class II | 866.5680 | Behring N LatexMyoglobinReagent | 6/01/96 | K902154 |
| COBAS INTEGRARheumatoid Factors | Rheumatoidfactorimmunologicaltest system | Class II | 866.5775 | Behring N LatexRF Reagent | 10/20/94 | K942328 |
| PlasmachromCalibrator | Calibrator | Class II | 862.1150 | Behring N ProteinStandard Plasma | 4/7/88 | K883662 |
| PlasmachromControls | Quality controlmaterial (assayedand unassayed) | Class I | 862.1660 | N/T ProteinControl Py | 4/17/96 | K951012 |
| Roche FERR TStandard | Calibrator | Class II | 862.1150 | Behring N FerritinStandard | 3/27/95 | K950707 |
| Roche FERR/MYOT Control | Quality controlmaterial (assayedand unassayed) | Class I | 862.1660 | Behring N FerritinControls | 3/27/95 | K950707 |
| Behring NMyoglobinControls | 6/01/96 | K902154 | ||||
| Roche MYO TStandard | Calibrator | Class II | 862.1150 | Behring NMyoglobinStandard | 6/01/96 | K902154 |
| Roche RF TStandard | Calibrator | Class II | 862.1150 | Behring N RFStandard | 10/20/94 | K942328 |
III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:
Table 1, presented above, identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
IV. Description of the Device/Statement of Intended Use:
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
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Through this submission, it is the intention of Roche to gain clearance of an additional 4 COBAS Reagent Cassettes and 6 ancillary reagents. These are the COBAS INTEGRA Cassette for Antithrombin III, COBAS INTEGRA Cassette for Ferritin, COBAS INTEGRA Cassette for Myoglobin, COBAS INTEGRA Cassette for Rheumatoid Factors, Roche Plasmachrom Calibrator, Roche Plasmachrom N & P Controls, Roche FERR T Standard, Roche FERR/MYO T Control, Roche MYOT Standard, and Roche RF Standard II. The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYOT Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Calcium. The performance of the COBAS INTEGRA Reagent Cassette for Calcium has been improved due to the use of new instrument parameters .
-
V . Summary of the technological characteristics of the device new in comparison to those of the predicate.
Tables 2-6 attached to this summary 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 2-6 attached to this summary demonstrate the results of clinical and nonclincal 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.
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Table 2
COBAS INTEGRA Cassette for AT III
| COBAS INTEGRACassette forAntithrombin III | Berichrom AT III (A) | |
|---|---|---|
| Methodology | Kinetic colorimetric test | Kinetic colorimetric test |
| Sample type | Plasma (citrate) | Plasma |
| Reported measuring units | % | % |
| Calibrator | Plasmachrom Calibrator(lyophilized human plasma)Calibrator value: 102% | Behring N Protein StandardPlasma (lyophilized humanplasma)Calibrator Value: 87% |
| Controls | Plasmachrom N & P Controls(lyophilized human plasma)Control N: 99.4%Control P: 61.1% | N/T Protein Control Py(lyophilized human plasma)Control N: 92%Control P: 34% |
| Reagent (active ingredients) | TRISNaClCitrateBSAHeparinThrombinD-phenylalanyl-prolyl-arginyl-4-acetylanilide | Thrombintos-gly-pro-arg-ANBA-IPATRIS |
| Performance Characteristics: | ||
| Assay range | 0-150% | 0-140% |
| Precision (Day-to-day) | 4.1% at 51.9%2.8% at 105.7% | Normal plasma - 1.0-2.5%Pathological plasma-1.5-3.0% |
| Accuracy | N = 200R = 0.973 vs. BerichromReagent | R = > 0.95 |
| Sensitivity (Analytical) | 1.6 X 10-3 ΔA/min per %change in AT III activity | Not specified in labeling |
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Accuracy
Sensitivity (Analytical)
1.3% at 30 ug/L 1.5% at 50 ug/L 0.9% at 200 ug/L
y = 1.01x - 0.37 ug/L vs. enzyme immunoassay
N = 44
5 ug/L
Table 3
COBAS INTEGRA Cassette for Ferritin
| COBAS INTEGRACassette for Ferritin | Behring N LatexFerritin Reagent onBehring Nephelometer | |||
|---|---|---|---|---|
| Methodology | Immunoturbidimetric test forFerritin | Immunoturbidimetric test forFerritin | ||
| Sample type | Serum | Serum | ||
| Reported measuring units | ug/L | ug/L | ||
| Calibrator | Roche FERR T Standard(human sourced)0, 12.5, 50, 100, 200, & 300ug/L | Behring N Ferritin Standard(human sourced)344 ug/L | ||
| Controls | Roche FERR/MYO T Control(lyophilized human serumw/added BSA)Ferritin: 126 ± 13 ug/LMyoglobin: 115 ± 12 ug/L | Behring N Ferritin Controls(human sourced)Control 1: 20.2 ug/LControl 2: 153 ug/L | ||
| Reagent (active ingredients) | R1. Glycine bufferR2. Latex particles coatedwith anti-human ferritin(rabbit) in glycine buffer | R1. Freeze dried polystyreneparticles coated with rabbitanti-human ferritinR2. Buffered solution ofrabbit serumR3. buffered solution ofdetergents | ||
| Performance Characteristics: | ||||
| Assay range | 0-300 ug/L0-3000 ug/L w/postdilution | 5-320 ug/L | ||
| Precision (Within-run) | 9.9 % at 19 ug/L1.2 % at 260 ug/L | 3.8% at 5 ug/L1.5% at 15 ug/L |
N = 188
Reagent
< 10 ug/L
y = 0.80x + 2.9 ug/L vs.
Behring N Latex Ferritin
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radioimmunoassay
25 ug/L
Table 4
COBAS INTEGRA Cassette for Myoglobin
| COBAS INTEGRACassette for Myoglobin | Behring N LatexMyoglobin Reagent | |
|---|---|---|
| Methodology | Immunoturbidimetric test forMyoglobin | Immunoturbidimetric test forMyoglobin |
| Sample type | Serum and plasma (heparin,EDTA, & fluoride) | Serum and plasma |
| Reported measuring units | ug/L | ug/L |
| Calibrator | Roche MYO T Standard(sourced from human skeletalmuscle in liquid form)0, 62.5, 125, 250, & 500ug/L | Behring N MyoglobinStandard (lyophilized humanserum)785 ng/mL |
| Controls | Roche FERR/MYO T Control(lyophilized human serumw/added BSA)Ferritin: 126 ± 13 ug/LMyoglobin: 115 ± 12 ug/L | Behring N MyoglobinControl (lyophilized humanserum)106 ng/mL |
| Reagent (active ingredients) | R1. Glycine buffer w/ BSAand immunoglobulins (rabbit)R2. Latex particles in glycinebuffer coated w/ anti-myoglobin (rabbit) | R1. lyophilisate ofpolystyrene particles coatedwith rabbit anti-humanmyoglobinR2. buffered rabbit serumsoln.R3. detergent soln. |
| Performance Characteristics: | ||
| Assay range | 0-500 ug/L0-5000 IU/mL w/postdilution | 25-400 ug/L |
| Precision (Day-to-day) | 1.4% at 46 ug/L0.6% at 312 ug/L | 4.8% at 85 ug/L4.2% at 160 ug/L5.0% at 310 ug/L |
| Accuracy | N = 230y = 0.91x + 15 ug/L vs.Behring N Latex Myoglobin | N = 117y = 0.95X - 4.33 vs.radioimmunoassay |
Reagent
3 ug/L
Sensitivity (Analytical)
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Table 5
COBAS INTEGRA Cassette for Rheumatoid Factors
| COBAS INTEGRACassette for RheumatoidFactors | Behring N Latex RFReagent on BehringNephelometer | |||
|---|---|---|---|---|
| Methodology | Immunoturbidimetric test forRF | Immunoturbidimetric test forRF | ||
| Sample type | Serum | Serum | ||
| Reported measuring units | IU/mL | IU/mL | ||
| Calibrator | Roche RF T Standard II(liquid human serum)10, 20, 40, 80, &160 IU/mL | Behring N RF Standard(lyophilized human serum)73 IU/mL | ||
| Controls | Roche RF/ASO T Control II(K954992) | Behring N RheumatologySL Controls | ||
| Reagent (active ingredients) | R1. Acceleratorpolyethylene glycol in glycinebuffer with bovine serumalbuminR2. Latex particles coatedwith human IgG in glycinebuffer | R1. Lyophilisate ofpolystyrene particles coatedwith antigen-antibodycomplex of human gamma-globulin/ anti-humangamma-globulin from sheepR2. aqueous solution ofpolyethylene glycol | ||
| Performance Characteristics: | ||||
| Assay range | 10-120 IU/mL10-600 IU/mL w/postdilution | 10-600 IU/mL | ||
| Precision (Day-to-day) | 8.0% at 32 IU/mL5.0% at 125 IU/mL | 9.3% at 92 IU/mL6.2% at 155 IU/mL6.6% at 306 IU/mL | ||
| Accuracy | N = 244$y = 0.70x + 12 IU/mL$ vs.Behring N Latex RF Reagent | N = 72$y = 0.99 x - 20 IU/mL$ vs.enzyme immunoassay | ||
| Sensitivity (Analytical) | 10 IU/mL | 10 IU/mL |
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Table 6
COBAS INTEGRA Cassette for Calcium
| COBAS INTEGRACassette for Calcium(Modified) | COBAS INTEGRACassette for Calcium(Cleared) | BoehringerMannheimCalcium on Hitachi911 | |
|---|---|---|---|
| Methodology | Colorimetrico-Cresolphthaleincomplexone | Colorimetrico-cresolphthaleincomplexone | Colorimetrico-cresolphthaleincomplexone |
| Sample type | Serum, heparinizedplasma and urine | Serum, heparinizedplasma and urine | Serum, heparinizedplasma and urine |
| Calibrator | Roche Calibrator(K942706) | Roche Calibrator(K942706) | Boehringer MannheimPrecical Calibrato r Serum |
| Reagent (activeingredients) | 1. o-Cresolphthaleincomplexone2. 8-Hydroxyquinoline3. CAPS4. NaOH | 1. o-Cresolphthaleincomplexone2. 8-Hydroxyquinoline3. CAPS4. NaOH | 1. 4-Aminobutyric acid2. o-Cresolphthaleincomplexone3. 8-Hydroxyquinoline4. HCI |
| Performance Characteristics: | |||
| Assay range | Serum, plasma:0-20 mg/dLUrine:0-28 mg/dL0-140 mg/dLw/postdilution | Serum, plasma:0-20 mg/dLUrine:0-100 mg/dL | Serum, plasma:0-15 mg/dL0-24.9 w/postdilutionUrine:0-15 mg/dL0-60 mg/dLw/postdilution |
| Precision(Total) | Serum, plasma:3.5% at 9.2 mg/dL3.1% at 13.6 mg/dLUrine:0.91% at 5.6 mg/dL1.1% at 23.7 mg/dL | Serum, plasma:2.1 % at 7.9 mg/dL1.8 % at 10.2 mg/dLUrine:2.8% at 3.9 mg/dL0.77% at 18 mg/dL | Serum, plasma:1.6 % at 8.9 mg/dL1.2 % at 9.7 mg/dL1.3% at 12.5 mg/dLUrine:2.2% at 2.9 mg/dL1.7% at 7.8 mg/dL1.4% at 36.7 mg/dL |
| Accuracy | N = 196R = 0.987 vs. BMHitachi 911 | N = 240R = 0.960 vs. BMHitachi 911 | N = 53R = 0.997 vs. BMHitachi 717 |
| Sensitivity(Analytical) | $4.0 X 10^{2}$ AA per mg/dLof calcium | $3.2 X 10^{2}$ AA per mg/dLof calcium | Not specified in labeling |
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.