(86 days)
The cassette COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6) contain an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The cassette COBAS INTEGRA a-Amylase EPS Pancreatic (AMY-P / AMYUP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of pancreatic or-amylase in serum, plasma, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
The cassette COBAS INTEGRA C-reactive Protein (Latex), (CRPLX) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human C-reactive protein in serum and plasma. Measurements of C-reactive protein aids in evaluation of the amount of injury to tissue.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. 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°C. 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. Through this submission, it is the intention of Roche to gain clearance for three additional COBAS Reagent Cassettes. These are the COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6), the COBAS INTEGRA a-Amylase EPS Pancreatic (AMY-P / AMYUP), and the COBAS INTEGRA C-Reactive Protein (Latex), (CRPLX).
The provided text is a 510(k) Summary for Roche COBAS® INTEGRA Reagent Cassettes, detailing the characteristics and performance of three new reagent cassettes (Alkaline Phosphatase IFCC liquid, α-Amylase EPS Pancreatic, and C-Reactive Protein (Latex)) compared to their legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet in the same way modern AI/ML device submissions would. Instead, the "Performance Characteristics" section for each proposed device is presented alongside the performance of its predicate device, implying that equivalence in these characteristics is the underlying acceptance criterion for substantial equivalence.
Since specific acceptance criteria are not called out, I will present the reported performance characteristics for the new devices. The implicit acceptance criterion is "comparable performance to the predicate device."
| Performance Characteristic | COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 & ALPL6) (Proposed) | COBAS INTEGRA α-Amylase EPS Pancreatic (AMY-P / AMYUP) (Proposed) | COBAS INTEGRA C-Reactive Protein (Latex) (CRPLX) (Proposed) | Implicit Acceptance Criteria (Comparable to Predicate) |
|---|---|---|---|---|
| Intended Use | Quantitative determination of catalytic activity of alkaline phosphatase in serum and plasma | Quantitative determination of catalytic activity of pancreatic α-amylase in serum, plasma, and urine | Quantitative immunological determination of human C-reactive protein in serum and plasma | Must align with predicate device's intended use |
| Methodology | Enzymatic colorimetric using 4-Nitrophenylphosphate (IFCC) | Enzymatic colorimetric using substrate 4,6-ethylidene-p-nitrophenyl-α-D-malto-heptaoside | Particle enhanced immunoturbidimetric | Must be similar to or provide equivalent results to predicate device's methodology |
| Sample Type | Serum and Plasma | Serum, plasma, and urine | Serum and Plasma | Must be identical to predicate |
| Calibrator | Roche Calibrator (human) (K942706) | Roche Calibrator (human) (K942706) | CRP T Standard (K951595) | Must be compatible and provide comparable calibration to predicate |
| Controls | Roche Control Serum N and P (human) (K972214) | Roche Control Serum N and P (human) (K972214) | CRP T Control (K954992), CRP T N Control (Exempt) | Must be compatible and provide comparable control performance to predicate |
| Reagents | AMP in vial B (liquid); 4-Nitrophenylphosphate in vial C (liquid) | -enzyme, two monoclonal antibodies (mouse) in vial A (liquid); -substrate in vial C (liquid) | R1 BSA and immunoglobulins (mouse), vials A & B; R2 Latex particles coated with anti-CRP (mouse), vial C (liquid) | Must be chemically and functionally similar to predicate's reagents |
| Assay Range | 0-1500 U/L | Serum/Plasma and Urine: 0 - 1500 U/L | 0 - 160 mg/L | Similar or improved range compared to predicate |
| Sensitivity | 3.7 x 10^-4 ΔA/min per U/L of ALP | Serum/Plasma and Urine: 2.8 x 10^-4 ΔA/min per U/L of pancreatic α-amylase | 0.25 mg/L | Similar or improved sensitivity compared to predicate |
| Precision (Within-run %CV) | Level 1: 2.3; Level 2: 0.55 | Serum Level 1: 1.2; Serum Level 2: 0.91; Urine Level 1: 1.094; Urine Level 2: 0.8796 | Level 1: 1.8; Level 2: 1.5 (Second Set) Level 1: 2.0; Level 2: 2.4 | %CV values should be within acceptable clinical laboratory limits and comparable to predicate |
| Precision (Total %CV) | Level 1: 2.7; Level 2: 1.3 | Serum Level 1: 1.7; Serum Level 2: 1.6; Urine Level 1: 1.2; Urine Level 2: 1.1 | Level 1: 2.9; Level 2: 2.7 (Second Set) Level 1: 2.5; Level 2: 2.4 | %CV values should be within acceptable clinical laboratory limits and comparable to predicate |
| Accuracy (Corr. Coeff. (r)) | 0.999 | Serum: 0.999; Urine: 0.999 | 0.993 | Correlation coefficient should be high (close to 1), indicating strong agreement with predicate or reference method |
| Accuracy (Linear Regression) | 1.00x + 0.15 U/L | Serum: 1.03x + 0.3 U/L; Urine: 1.00x + 1.4 U/L | 1.07x - 6.2 mg/L | Slope should be close to 1 and y-intercept close to 0, indicating minimal bias relative to predicate or reference method |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the clinical samples used to evaluate the performance characteristics (precision and accuracy) of the new reagent cassettes.
-
COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6):
- Accuracy Sample Size (n): 252
- Data Provenance: Not specified, but generally for in vitro diagnostic (IVD) devices, these studies use patient samples collected in a clinical laboratory setting. The origin (country) and retrospective/prospective nature are not detailed in this summary.
-
COBAS INTEGRA α-Amylase EPS Pancreatic (AMY-P / AMYUP):
- Accuracy Sample Size (n):
- Serum: 246
- Urine: 106
- Data Provenance: Not specified, same general assumptions as above.
- Accuracy Sample Size (n):
-
COBAS INTEGRA C-Reactive Protein (Latex) (CRPLX):
- Accuracy Sample Size (n): 244
- Data Provenance: Not specified, same general assumptions as above.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For IVD devices like these, "ground truth" for method comparisons is typically established by running the same samples on a legally marketed predicate device or a highly accurate reference method. It does not involve human expert consensus in the way image-based diagnostics might.
4. Adjudication Method for the Test Set
This is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, and their disagreements need to be resolved. For quantitative chemical assays, the measurement itself is the "reader," and comparison is made to another assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is an in-vitro diagnostic reagent cassette for automated analyzers, not an AI or imaging device involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance data presented (assay range, sensitivity, precision, accuracy) represent the standalone performance of the reagent cassettes on the COBAS INTEGRA Analyzer. There is no human-in-the-loop component being evaluated for the measurement itself, only for the instrument's operation and result interpretation by laboratory personnel.
7. The Type of Ground Truth Used
For these types of in vitro diagnostic assays, the "ground truth" for the accuracy studies is implicitly established by comparing the results from the new device to those obtained from the legally marketed predicate device (or a recognized reference method). The correlation coefficients and linear regression data are direct comparisons to the predicate. For example, the accuracy section "Corr. Coefficient (r)" and "Linear regression" are direct comparisons between the proposed device and the cleared predicate device.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the same way it would be for an AI/ML device. For chemical reagents, "training" typically refers to the R&D and optimization phase to develop the reagent formulation and instrument application. It's not a discrete "training set" of patient data used to optimize an algorithm parameters that are then locked.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, this is not provided and likely not applicable in the context of an AI/ML device. The "ground truth" during reagent development would involve analytical methods to confirm the chemical properties and performance of the reagents.
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Image /page/0/Picture/1 description: The image shows the Roche logo. The logo consists of the word "Roche" in bold, sans-serif font, enclosed within a hexagon. The hexagon is outlined in black, and the word "Roche" is also in black.
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.
The assigned 510(k) number is: K981897
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 May 29, 1998
Contact: Rita Smith Senior Regulatory Affairs Associate Phone: (908) 253-7545 Fax: (908) 253-7547
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II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Product Name | Classification Name | Product Code | CFR Number and Regulatory Class |
|---|---|---|---|
| COBAS INTEGRAAlkaline Phosphatase IFCC liquid(ALPL2) (ALPL6) | Nitrophenylphosphate, alkaline phosphatase or isoenzyme | CJE | 862.1050Class II |
| COBAS INTEGRA αAmylase EPSPancreatic(AMY-P / AMYUP) | Catalytic methods, Amylase | JFJ | 862.1070Class II |
| COBAS INTEGRA C-ReactiveProtein (Latex) (CRPLX) | C-reactive protein Immunological test system | DCN | 862.5270Class II |
Table 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 ProductName | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|
| COBAS INTEGRAAlkaline Phosphatase IFCC liquid(ALPL2) (ALPL6) | COBAS INTEGRA AlkalinePhosphatase IFCC (ALP) | 9/8/95 | K951595 |
| COBAS INTEGRA αAmylase EPSPancreatic(AMY-P / AMYUP) | Boehringer Mannheim/ HitachiPancreaticα-Amylase liquid | 12/19/89 | K895880 |
| COBAS INTEGRA C-ReactiveProtein (Latex) (CRPLX) | COBAS INTEGRA C-ReactiveProtein (CRP) | 9/8/95 | K951595 |
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Description of the Device/Statement of Intended Use: IV.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. 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 108 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); January 21, 1997 (K964457); August 12, 1997 (K972250); and May 21, 1998 (K974695).
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°C. 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 to gain clearance for three additional COBAS Reagent Cassettes. These are the COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6), the COBAS INTEGRA a-Amylase EPS Pancreatic (AMY-P / AMYUP), and the COBAS INTEGRA C-Reactive Protein (Latex), (CRPLX).
Note: The Alkaline Phosphatase reagent cassette in two sizes: the 200 test cassette (ALPL2) and the 600 test cassette (ALPL6).
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Summary of the technological characteristics of the new device in comparison to V. those of the predicate.
Tables 3-5 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 3-5 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.
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COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6)
The cassettes COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6) contain an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of alkaline phosphatase in serum and plasma.
| COBAS INTEGRA AlkalinePhosphatase IFCC liquid (ALPL2and ALPL6)(proposed) | COBAS INTEGRA AlkalinePhosphatase IFCC (ALP)(cleared) K951595 | |||
|---|---|---|---|---|
| Intended Use | quantitative determination of the catalyticactivity of alkaline phosphatase in serumand plasma | quantitative determination of thecatalytic activity of alkaline phosphatasein serum and plasma | ||
| Methodology | enzymatic colorimetric using4-Nitrophenylphosphate (IFCC) | enzymatic colorimetric using4-Nitrophenylphosphate (IFCC) | ||
| Sample type | Serum and Plasma | Serum and Plasma | ||
| Calibrator | Roche Calibrator (human)(K942706) | Roche Calibrator (human)(K942706) | ||
| Controls | Roche Control Serum N and P (human)(K972214) | Roche Control Serum N and P (human)(K972214) | ||
| Reagents | AMP in vial B (liquid)4-Nitrophenylphosphate in vial C (liquid) | AMP in vial A and B (liquid)4-Nitrophenylphosphate in vial C(granulate) | ||
| Performance Characteristics: | ||||
| Assay range | 0-1500 U/L | 0 - 2300 U/L | ||
| Sensitivity | 3.7 x 10-4 ΔA/min per U/L of ALP | 4.0 x 10-4 ΔA/min per U/L of ALP | ||
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (U/L) | 45 | 236 | 85 | 451 |
| % CV (within-run) | 2.3 | 0.55 | 1.2 | 1.3 |
| % CV (total) | 2.7 | 1.3 | 1.6 | 2.0 |
| Accuracy: | ||||
| Sample size (n) | 252 | 234 | ||
| Corr. Coefficient (r) | 0.999 | 0.999 | ||
| Linear regression | 1.00x + 0.15 U/L | 1.06x - 6 U/L |
Table 3 - COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6)
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COBAS INTEGRA α-Amylase EPS Pancreatic (AMY-P / AMYUP):
The cassette Roche COBAS INTEGRA α-Amylase EPS Pancreatic (AMY-P / AMYUP) contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the quantitative determination of the catalytic activity of pancreatic cu-amylase in serum, plasma, and urine.
| COBAS INTEGRA α-AmylaseEPS Pancreatic(AMY-P / AMYUP)(proposed) | Boehringer Mannheim/HitachiPancreatic A-Amylaseliquid reagent(cleared) K895880 | |||
|---|---|---|---|---|
| Methodology | Enzymatic colorimetric using substrate4,6-ethylidene-p-nitrophenyl-α-D-malto-heptaoside | Enzymatic colorimetric using substrate4,6-ethylidene-p-nitrophenyl-α-D-malto-heptaoside | ||
| Sample type | Serum, plasma and urine | Serum, plasma, and urine | ||
| Calibrator | Roche Calibrator (human)(K942706) | Calibrator for automated systems | ||
| Controls | Roche Control Serum N and P (human)(K972214) | Precinorm® U, Precinorm® E,Precipath® U, Precipath® E | ||
| Reagents | -enzyme, two monoclonal antibodies(mouse)in vial A (liquid)-substrate in vial C (liquid) | R1 enzyme, two monoclonal antibodies(mouse)R2 substrate | ||
| Performance Characteristics: | ||||
| Assay range | Serum/Plasma and Urine:0 - 1500 U/L | Serum/Plasma and Urine:0 - 1500 U/L | ||
| Sensitivity | Serum/Plasma and Urine:$2.8 x 10^{-4}$ ΔA/min per U/L of pancreaticα-amylase | Serum/Plasma and Urine:3 U/L | ||
| Precision (Serum): | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (U/L) | 32 | 184 | 35.7 | 53.9 |
| % CV (within-run) | 1.2 | 0.91 | 0.9 | 0.5 |
| % CV (total) | 1.7 | 1.6 | 1.5 | 1.9 |
| Precision (Urine): | Level 1 | Level 2 | Level 1 | Level 2 |
| Mean (U/L) | 59 | 180 | 31.7 | 98.4 |
| % CV (within-run) | 1.094 | 0.8796 | 0.8 | 0.4 |
| % CV (total) | 1.2 | 1.1 | 1.7 | 0.8 |
| Accuracy (Serum): | ||||
| Sample size (n) | 246 | 51 | ||
| Corr. Coefficient (r) | 0.999 | 1.000 | ||
| Linear regression | 1.03x + 0.3 U/L | 1.11x + 0.2 | ||
| Accuracy (Urine): | ||||
| Sample size (n) | 106 | 51 | ||
| Corr. Coefficient (r) | 0.999 | 1.000 | ||
| Linear regression | 1.00x + 1.4 U/L | 1.18x + 0.4 |
Table 4 - COBAS INTEGRA α-Amylase EPS Pancreatic (AMY-P/AMYUP)
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COBAS INTEGRA C-Reactive Protein (Latex) (CRPLX)
The cassette C-reactive Protein (Latex), (CRPLX) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human C-reactive protein in serum and plasma.
| COBAS INTEGRA C-ReactiveProtein (Latex) (CRPLX)(proposed) | COBAS INTEGRA C-ReactiveProtein (CRP)(cleared) K951595 | |
|---|---|---|
| Intended Use | quantitative immunological determinationof human C-reactive protein in serum and plasma | quantitative immunologicaldetermination of human C-reactiveprotein in serum and plasma |
| Methodology | Particle enhanced immunoturbidimetric | Immunoturbidimetric |
| Sample type | Serum and Plasma | Serum and Plasma |
| Calibrator | CRP T Standard (K951595) | CRP T Standard (K951595) |
| Controls | CRP T Control (K954992)CRP T N Control (Exempt) | CRP T Control (K954992) |
| Reagents | R1 BSA and immunoglobulins (mouse),vials A & BR2 Latex particles coated with anti-CRP(mouse), vial C (liquid) | R1 Accelerator, vials A & BR2 Anti-CRP T antiserum (sheep). vialC |
| Performance Characteristics: | ||
| Assay range | 0 - 160 mg/L | 5 - 160 mg/L |
| Sensitivity | 0.25 mg/L | 5 mg/L |
| Precision: | Level 1 | Level 2 |
| Mean (mg/L) | 6.2 | 142 |
| Level 1 | Level 2 | |
| 53 | 114 | |
| % CV (within-run) | 1.8 | 1.5 |
| 2.0 | 2.4 | |
| % CV (total) | 2.9 | 2.7 |
| 2.5 | 2.4 | |
| Accuracy: | ||
| Sample size (n) | 244 | 234 |
| Corr. Coefficient (r) | 0.993 | 0.999 |
| Linear regression | $1.07x - 6.2 mg/L$ | $1.10x + 5.5 mg/L$ |
Table 5 - COBAS INTEGRA C-Reactive Protein (Latex) (CRPLX)
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 26 1998
Rita Smith .Senior Regulatory Affairs Associate Roche Diagnostics Systems, Inc. 1080 U.S. Hiqhway 202 08876-3771 Somerville, New Jersey
Re : K981897 Roche COBAS® INTEGRA Reagent Cassettes Regulatory Class: II Product Code: CJE, JFJ, DCK Dated: August 13, 1998 Received: August 17, 1998
Dear Ms. Smith:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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.
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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 Gutman
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-----------
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Page 1 of 1 .
510(k) Number (if known): K981897
Roche COBAS INTEGRA Alkaline Phosphatase liguid Reagent Cassette Device Name: (ALPL2) (ALPL6) Art. No. 07 6673 9, 07 5996 1
Roche COBAS INTEGRA Pancreatic a-Amylase EPS Reagent Cassette (AMY-P / AMYUP) Art. No. 07 6662 3
Roche COBAS INTEGRA C-Reactive Protein (Latex) Reagent Cassette (CRPLX) Art. No. 07 6493 0
Indications for Use:
The cassette COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6) contain an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The cassette COBAS INTEGRA a-Amylase EPS Pancreatic (AMY-P / AMYUP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of pancreatic or-amylase in serum, plasma, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
The cassette COBAS INTEGRA C-reactive Protein (Latex), (CRPLX) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human C-reactive protein in serum and plasma..... Measurements of C-reactive protein aids in evaluation of the amount of injury to குக்குடி (ff)
Division of Clinical Laboratory Devices
510(k) Number __
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K981897 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.