(27 days)
The cassette COBAS INTEGRA Serum Barbiturates contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.
The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Barbiturates on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of barbiturates in human specimens.
The cassette COBAS INTEGRA Serum Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of benzodiazepines and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.
The Abuscreen ONLINE Serum Benzodiazepines Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Benzodiazepines on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of benzodiazepines in human specimens.
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 two additional COBAS Reagent Cassettes and their associated calibrator sets. These are: the COBAS INTEGRA Serum Barbiturates (SBARB) Reagent Cassette, the Abuscreen ONLINE Serum Barbiturates Calibrators, the COBAS INTEGRA Serum Benzodiazepines (SBENZ) Reagent Cassette, and the Abuscreen ONLINE Serum Benzodiazepines Calibrators.
Here's an analysis of the acceptance criteria and study information for the Roche COBAS® INTEGRA Reagent Cassettes and Calibrators, based on the provided text:
Important Note: The provided document is a 510(k) Summary for a medical device cleared in 1998. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through a standalone, comprehensive clinical trial with pre-defined acceptance criteria in the way a new, high-risk device might today. The "acceptance criteria" detailed below are derived from the performance characteristics presented for comparison with the predicate device. The study is primarily a comparative effectiveness study against the predicate, alongside internal analytical validation.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a pass/fail format with specific targets that the device must meet in a prospective study. Instead, it presents performance characteristics of the new device alongside those of its predicate for comparison, implying that the new device's performance should be comparable or substantially equivalent to the predicate. The "reported device performance" refers to the values presented for the COBAS INTEGRA system.
A. COBAS INTEGRA Serum Barbiturates (SBARB)
| Characteristic | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (COBAS INTEGRA SBARB) |
|---|---|---|
| Intended Use | Detection of barbiturates/metabolites in human serum/plasma for toxicological screening, diagnosis, and treatment of use/overdose. | Detection of barbiturates/metabolites in human serum/heparinized plasma for toxicological screening, management of use/overdose. |
| Methodology | Fluorescence polarization | Fluorescence polarization |
| Sample Type | Serum and Plasma | Serum and Plasma |
| Assay Range | 0.70 - 40 µg/mL | 0.03 - 4 µg/mL (0.03 - 80 µg/mL with postdilution) |
| Cutoff Conc. | 2.0 µg/mL | 0.5 µg/mL |
| Sensitivity | 0.07 µg/mL | 0.03 µg/mL |
| Precision (Within-run % CV) | Level 1: 3.18%, Level 2: 3.47%, Level 3: 4.38% | Level 1: 4.1%, Level 2: 4.1%, Level 3: 2.3% |
| Precision (Total % CV) | Level 1: 4.00%, Level 2: 3.92%, Level 3: 4.73% | Level 1: 5.0%, Level 2: 4.2%, Level 3: 2.9% |
| Accuracy (Agreement vs GC/MS) | 79 positive, 14 negative (total 93 cases) | 37 positive, 10 negative (total 47 cases) |
| Reproducibility (Agreement vs Predicate ADX) | 69 positive, 123 negative | 35 positive, 12 negative |
B. COBAS INTEGRA Serum Benzodiazepines (SBENZ)
| Characteristic | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (COBAS INTEGRA SBENZ) |
|---|---|---|
| Intended Use | Detection of benzodiazepines/metabolites in human serum/plasma for toxicological screening, diagnosis, and treatment of use/overdose. | Detection of benzodiazepines/metabolites in human serum/heparinized plasma for toxicological screening, management of use/overdose. |
| Methodology | Fluorescence polarization | Fluorescence polarization |
| Sample Type | Serum and Plasma | Serum and Plasma |
| Assay Range | 12 - 1000 ng/mL | 3 - 200 ng/mL (3 - 2000 ng/mL with postdilution) |
| Cutoff Conc. | 12.0 ng/mL | 3 ng/mL |
| Sensitivity | 12.0 ng/mL | 3 ng/mL |
| Precision (Within-run % CV) | Level 1: 3.19%, Level 2: 1.86%, Level 3: 3.41% | Level 1: 5.5%, Level 2: 1.9%, Level 3: 1.1% |
| Precision (Total % CV) | Level 1: 4.98%, Level 2: 3.73%, Level 3: 5.98% | Level 1: 5.4%, Level 2: 2.7%, Level 3: 2.0% |
| Accuracy (Agreement vs GC/MS) | 76 positive, 38 negative (total 114 cases) | 46 positive, 28 negative (total 74 cases) |
| Reproducibility (Agreement vs Predicate TDX) | 76 positive, 83 negative | 46 positive, 20 negative |
2. Sample Size Used for the Test Set and the Data Provenance
-
COBAS INTEGRA Serum Barbiturates (SBARB):
- Accuracy (compared to GC/MS): 47 samples (37 positive, 10 negative)
- Accuracy (compared to Predicate ADX): 47 samples (35 positive, 12 negative)
- Precision: Not explicitly stated, but typically involves multiple replicates across several runs for each level tested. Given the three levels and %CV calculation, a common practice would be 20 replicates for 2-3 levels over 2-3 days, resulting in at least 40-60 measurements per level. The exact number of individual patient samples used to derive these mean and CV values is not specified, but these are typically control or spiked samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective analytical performance evaluations conducted by the manufacturer as part of the submission to demonstrate equivalence.
-
COBAS INTEGRA Serum Benzodiazepines (SBENZ):
- Accuracy (compared to GC/MS): 74 samples (46 positive, 28 negative)
- Accuracy (compared to Predicate TDX): 66 samples (46 positive, 20 negative)
- Precision: Similar to SBARB, not explicitly stated, but common practice would imply multiple replicates for each of the three levels tested.
- Data Provenance: Not explicitly stated. Likely retrospective analytical performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- For both assays (Barbiturates and Benzodiazepines), the ground truth for accuracy was established using GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is considered a "gold standard" analytical method for drug confirmation and quantification in toxicology.
- The document does not specify the number of human experts involved in interpreting the GC/MS results or their qualifications. The interpretation of GC/MS data is typically performed by trained laboratory personnel (e.g., analytical chemists, toxicologists) within a certified laboratory environment.
4. Adjudication Method for the Test Set
- For the accuracy studies using GC/MS as the ground truth, there is no mention of an adjudication method in the traditional sense (e.g., 2+1 physician review). The GC/MS result itself serves as the definitive determination. Discrepancies between the device and GC/MS would be investigated analytically rather than through expert consensus on the clinical classification.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This submission concerns in vitro diagnostic (IVD) reagent assays, which are standalone laboratory tests, not imaging devices or AI-assisted diagnostic tools that involve human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this entire submission effectively represents a standalone performance evaluation. The COBAS INTEGRA system, with these reagent cassettes, performs automated analysis. Its performance characteristics (precision, accuracy, sensitivity, assay range, cutoff) are measured directly based on the analytical results produced by the instrument and reagents, without immediate human intervention in the result generation itself. Human interaction would occur in sample loading, result review, and clinical interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The primary ground truth for the accuracy claims was:
- GC/MS (Gas Chromatography/Mass Spectrometry): This is a highly specific and sensitive analytical method for confirming and quantifying drugs, serving as the gold standard in toxicology for this type of test.
8. The Sample Size for the Training Set
- The document does not specify the sample size for a training set. For IVD assays based on established chemical principles (like fluorescence polarization immunoassay), there isn't a "training set" in the same way there would be for a machine learning or AI algorithm. The assay's parameters (e.g., antibody concentrations, reaction times, calibration curves) are developed and optimized by the manufacturer using internal R&D processes, but these are not explicitly detailed as a "training set" in the context of this 510(k) summary. The performance data presented are for the final, developed product.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not explicitly mentioned or applicable in the AI/machine learning sense for this device, the question of how its ground truth was established is not directly answerable from the provided text. The development and optimization of such assays rely on well-characterized samples (e.g., spiked samples, confirmed positive/negative clinical samples, reference materials) to establish robust analytical performance, but these are part of the R&D process rather than a formalized "training set" with ground truth in the context of this regulatory submission.
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Image /page/0/Picture/0 description: The image shows the text "K982551" written in a handwritten style. Below the text is the Roche logo, which consists of the word "Roche" inside of a hexagon. The text and logo are both black and are set against a white background.
AUG 1 8 1998
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: K982551
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 July 20, 1998
Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 (908) 253-7547 Fax:
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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 | ClassificationName | ProductCode | CFRNumber andRegulatory Class |
|---|---|---|---|
| COBAS INTEGRASerum Barbiturates (SBARB) | Enzyme Immunoassay,Barbiturates | DIS | 862.3150Class II |
| Abuscreen ONLINE SerumBarbiturates Calibrators | Calibrators. Drug Specific | DLJ | 862.3200Class II |
| COBAS INTEGRA SerumBenzodiazepines (SBENZ) | Enzyme Immunoassay,Benzodiazepines | JXM | 862.3170Class II |
| Abuscreen ONLINE SerumBenzodiazepines Calibrators | Calibrators. Drug Specific | DLJ | 862.3200Class 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 INTEGRASerum Barbiturates (SBARB) | Abbott ADX Barbiturates | 8/25/89 | K890690 |
| Abuscreen ONLINE SerumBarbiturates Calibrators | Abbott ADX Barbiturates | 8/25/89 | K890690 |
| COBAS INTEGRA SerumBenzodiazepines (SBENZ) | Abbott TDX BenzodiazepinesSerum | 11/29/88 | K883730 |
| Abuscreen ONLINE SerumBenzodiazepines Calibrators | Abbott TDX BenzodiazepinesSerum | 11/29/88 | K883730 |
| able | 1 |
|---|---|
| ું જ | 2 |
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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 109 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); May 21, 1998 (K974695) and June 5, 1998 (K980996).
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 two additional COBAS Reagent Cassettes and their associated calibrator sets. These are: the COBAS INTEGRA Serum Barbiturates (SBARB) Reagent Cassette, the Abuscreen ONLINE Serum Barbiturates Calibrators, the COBAS INTEGRA Serum Benzodiazepines (SBENZ) Reagent Cassette, and the Abuscreen ONLINE Serum Benzodiazepines Calibrators,
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Summary of the technological characteristics of the new device in comparison to V. those of the predicate.
Tables 3-4 outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagents and their corresponding calibrators in comparison to those of legally marketed predicate products.
Brief discussion of the clinical and nonclinical tests relied on for a determination of VI. substantial equivalence:
Tables 3-4 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 Serum Barbiturates (SBARB)
The cassette COBAS INTEGRA Serum Barbiturates contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.
Abuscreen ONLINE Serum Barbiturates Calibrators
The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Barbiturates on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of barbiturates in human specimens.
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Table 3 - COBAS INTEGRA Serum Barbiturates (SBARB) and Abuscreen ONLINE Serum Barbiturates Calibrators
| COBAS INTEGRA SerumBarbiturates and Abuscreen ONLINESerum Barbiturates Calibrators | Abbott ADX Barbiturates(cleared) K890690 | |||||
|---|---|---|---|---|---|---|
| Intended Use | for the detection of barbiturates and theirmetabolites in human serum or heparinizedplasma, intended for used in toxicologicalscreenings where the analytical result is usedin the management of barbiturate use oroverdose | for the detection of various barbituratesand metabolites in human serum orplasma, measurements obtained are usedin the diagnosis and treatment ofbarbiturates use or overdose, intended tobe used solely in toxicological screeningsituations | ||||
| Methodology | fluorescence polarization | fluorescence polarization | ||||
| Sample type | Serum and Plasma | Serum and Plasma | ||||
| Reagents | R1: Antibody Reagent:Anti-secobarbital polyclonal (sheep)R2: Diluent: buffer with stabilizerR3: Tracer: fluorecein-labeled secobarbitalderivative in buffer with stabilizer | S: barbiturates serum antiserum (sheep)P: pretreatment solution buffer withsurfactant and protein stabilizersT: barbiturates serum fluorescein tracer inbuffer with surfactant and proteinstabilizers | ||||
| Controls | COBAS-FP TDM Multianalyte Controls(K951595) [Level I and II] | Trilevel serum barbiturates controlscontained in ADX kit | ||||
| Calibrators | Abuscreen ONLINE Serum BarbituratesCalibrators | Barbiturates Calibrators contained in ADXkit | ||||
| Matrix: | human serum | human serum | ||||
| Levels (µg/mL): | Cal 1: 0Cal 2: 0.5Cal 3: 1Cal 4: 2Cal 5: 4 | A: 0.0B: 2C: 5D: 10E: 20F: 40 | ||||
| Performance Characteristics: | ||||||
| Assay range | 0.03 - 4 µg/mL0.03 - 80 µg/mL (with postdilution) | 0.70 - 40 µg/mL | ||||
| Cutoff Conc. | 0.5 µg/mL | 2.0 µg/mL | ||||
| Sensitivity | 0.03 µg/mL | 0.07 µg/mL | ||||
| Precision:Mean (µg/mL) | Level 1 | Level 2 | Level 3 | |||
| 0.5 | 1.1 | 1.9 | Level 12.70 | Level 27.07 | Level 326.27 | |
| % CV (within-run) | 4.1 | 4.1 | 2.3 | 3.18 | 3.47 | 4.38 |
| % CV (total) | 5.0 | 4.2 | 2.9 | 4.00 | 3.92 | 4.73 |
| Accuracy:(see package insertsfor more detail) | GC/MS | INTEGRA | FPIA | EIA | ||
| +3710 | 3512 | 2423 | 1334 | GC/MS+7914 | ADX69123 |
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COBAS INTEGRA Serum Benzodiazepines (SBENZ)
The cassette COBAS INTEGRA Serum Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of benzodiazepines and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.
Abuscreen ONLINE Serum Benzodiazepines Calibrators
The Abuscreen ONLINE Serum Benzodiazepines Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Benzodiazepines on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of benzodiazepines in human specimens.
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Table 4 - COBAS INTEGRA Serum Benzodiazepines (SBENZ) and Abuscreen ONLINE Serum Benzodiazepines Calibrators
| COBAS INTEGRA Serum | Abbott TDX Benzodiazepines | ||||||
|---|---|---|---|---|---|---|---|
| Benzodiazepines and Abuscreen | |||||||
| ONLINE Serum Benzodiazepines | (cleared) K890690 | ||||||
| Calibrators | |||||||
| Intended Use | for the detection of benzodiazepines andtheir metabolites in human serum orheparinized plasma, intended for used intoxicological screenings where the analyticalresult is used in the management ofbenzodiazepine use or overdose | for the detection of variousbenzodiazepines and metabolites in humanserum or plasma, measurements obtainedare used in the diagnosis and treatment ofbenzodiazepine use or overdose, intendedto be used solely in toxicological screeningsituations | |||||
| Methodology | fluorescence polarization | fluorescence polarization | |||||
| Sample type | Serum and Plasma | Serum and Plasma | |||||
| Reagents | R1: Antibody Reagent:Anti-benzodiazepine polyclonal (sheep)R2: Diluent: buffer with stabilizerR3: Tracer: fluorecein-labeledbenzodiazepine derivative in buffer withstabilizer | W: wash solutionS: barbiturates serum antiserum (sheep)P: pretreatment solution buffer withsurfactant and protein stabilizersT: barbiturates serum fluorescein tracer inbuffer with surfactant and proteinstabilizers | |||||
| Calibrators | Abuscreen ONLINE Serum BenzodiazepinesCalibrators | Benzodiazepines Calibrators contained inTDX kit | |||||
| Matrix: | human serum | human serum | |||||
| Levels (ng/mL): | Cal 1: 0Cal 2: 25Cal 3: 50Cal 4: 100Cal 5: 200 | A: 0.0B: 50C: 100D: 200E: 400F: 1000 | |||||
| Performance Characteristics: | |||||||
| Assay range | 3 - 200 ng/mL3 - 2000 ng/mL (with postdilution) | 12 - 1000 ng/mL | |||||
| Cutoff Conc. | 3 ng/mL | 12.0 ng/mL | |||||
| Sensitivity | 3 ng/mL | 12.0 ng/mL | |||||
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Mean (µg/mL) | 25.1 | 34.5 | 128.9 | 74.88 | 302.82 | 687.40 | |
| % CV (within-run) | 5.5 | 1.9 | 1.1 | 3.19 | 1.86 | 3.41 | |
| % CV (total) | 5.4 | 2.7 | 2.0 | 4.98 | 3.73 | 5.98 | |
| Accuracy:(see package insertsfor more detail) | GC/MS+- | INTEGRA | FPIAEIA | GC/ES+- | TDX | ||
| 4628 | 4620 | 4116228 | 7638 | 7683 |
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Image /page/8/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 8 1998
Rita Smith Senior Regulatory Affairs Associate Roche Diagnostics Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
Re : K982551 Roche COBAS® INTEGRA Serum and Abuscreen ONLINE Serum Barbiturates & Benzodiazepines Cassettes and Calibrators Regulatory Class: II Product Code: DIS, JXM, DLJ Dated: July 20, 1998 Received: July 22, 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, labelinq, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ 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 regulation may result in requlatory action. In addition, FDA may publish further announcements 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 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
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Page 1 of _ 2 _
510(k) Number (if known) K 982551
Roche COBAS INTEGRA Serum Barbiturates Cassette (SBARB) Device Name: Art. No. 07 6670 4
Abusceen ONLINE Serum Barbiturates Calibrators Art. No. 07 6672 0
Roche COBAS INTEGRA Serum Benzodiazepines Cassette (SBENZ) Art. No. 07 6669 0
Abuscreen ONLINE Serum Benzodiazepines Calibrators Art. No. 07 6671 2
Indications for Use:
ા :
The cassette COBAS INTEGRA Serum Barbiturates contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.
The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Barbiturates on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of barbiturates in human specimens.
(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
| Over-The-Counter Use (Optional Format 1-2-96) |
|---|
| ----------------------------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K982551 |
|---|---|
| --------------- | --------- |
າ ໄປ ເ
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Page 2 of of 2 _ _
Indications for Use (continued):
The cassette COBAS INTEGRA Serum Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of benzodiazepines and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.
The Abuscreen ONLINE Serum Benzodiazepines Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Benzodiazepines on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of benzodiazepines in human specimens.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).