(17 days)
COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert. For In Vitro Diagnostic Use
COMBITROL PLUS B / AUTOTROL PLUS B is a specially formulated, threelevel, aqueous liquid material intended for use to monitor all analytes measured by the Roche OMNI S Analyzer. COMBITROL PLUS B / AUTOTROL PLUS B provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. COMBITROL PLUS B / AUTOTROL PLUS B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, urea, and hematocrit, and suitable concentrations of dyes to simulate clinically relevant values of bilirubin, hemoglobin and hemoglobin derivatives: 02Hb, COHb, MetHb and HHb. COMBITROL PLUS B / AUTOTROL PLUS B is a non-hazardous aqueous solution containing no biological materials.
The provided text describes a 510(k) summary for the Roche COMBITROL PLUS B and Roche AUTOTROL PLUS B Multi Analyte Controls. This is a quality control material intended for monitoring and evaluating the analytical performance of the Roche OMNI S analyzer.
As this is a quality control device rather than a diagnostic or therapeutic device, the typical acceptance criteria and study designs (like those for AI algorithms or clinical efficacy) for patient-facing devices do not apply in the same way. The studies conducted are focused on the stability and precision of the control material itself, and its substantial equivalence to predicate devices.
Here's an analysis based on the information provided, tailored to a quality control device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and verifying performance requirements related to stability and precision.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | Comparison of technological characteristics, formulation, and intended use to predicate devices supports the claim of substantial equivalence. |
| - Similar intended use | Intended for use to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert. (Similar to predicate's monitoring function) |
| - Similar technological characteristics (analytes, matrix, container, fill volume, color) | See "Comparison of COMBITROL PLUS B and AUTOTROL PLUS B to predicate devices for substantial equivalency" table above. Generally similar, with some modifications (e.g., more analytes, different fill volume, color). These modifications are addressed by showing performance is maintained. |
| Performance Requirements: | |
| - Stability | Real-time evaluation of products with essentially similar formulation and failure mode supported stability. |
| - Precision | Test precision was conducted. (Specific results not detailed in this summary) |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated. The "test precision" study would have involved multiple measurements, but the number of runs or samples is not provided in this 510(k) summary.
- Data Provenance: Not explicitly stated. Given it's a product from Bionostics, Inc. in Devens, MA, USA, the testing was likely conducted in-house or by a contracted lab, presumably in the USA. The studies are non-clinical tests described as "real-time evaluation" and "test precision," implying prospective testing of the manufactured control material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to a quality control material. Ground truth in this context refers to the expected or reference values of the analytes within the control solution. These values are established through rigorous analytical methods and calibration processes inherent in the manufacturing of such controls, not typically by clinical experts establishing diagnostic "ground truth."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers evaluate cases and their interpretations need to be reconciled, especially in diagnostic imaging or pathology. For a quality control material, the performance is assessed against established analytical reference values or expected variations, not through human adjudication of diagnostic interpretations.
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
Not applicable. MRMC studies are designed for assessing the impact of a diagnostic tool (often AI) on human performance in interpreting cases. This device is a quality control material, not a diagnostic tool, and involves no "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a chemical quality control solution, not an algorithm.
7. The Type of Ground Truth Used
For quality control materials, the "ground truth" (or reference values) for the analytes (pH, PCO2, PO2, sodium, etc.) is established through:
- Reference Methods and Calibration: Precise analytical methods and highly calibrated instruments used during the manufacturing and assaying process to determine the concentration or activity of each analyte in the control material.
- Batch-to-Batch Consistency: Ensuring that each batch of control material consistently falls within a specified range relative to these reference values.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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BIONOSTICS
510(k) Summary*
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Sr. Director, QA & RA (978) 772-7070 x 220
Date of preparation of this summary: 8 August 2003
- Device trade or proprietary name: (2)
Roche COMBITROL PLUS B and Roche AUTOTROL PLUS B Muti Analyte Controls
Device common or usual name or classification name:
| Multi Analyte Control Solution, All Types (Assayed and Unassayed) | |||
|---|---|---|---|
| CLASSIFICATION | |||
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| MULTI-ANALYTE CONTROLS - ALL KINDS | 862.1660 | 75 JJY I | CHEMISTRY |
(3) Substantial Equivalence
This device is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:
Comparison of COMBITROL PLUS B and AUTOTROL PLUS B to predicate devices for substantial equivalency
| Characteristic | Predicate Devices | Modified Device |
|---|---|---|
| Name: | Blood Gas, Electrolyte,Metabolite Control | Roche COMBITROL PLUS BandRoche AUTOTROL PLUS B |
| Blood Gas, Electrolyteand CO-Oximetry Control | ||
| 510(k), Date: | K972868, 08/28/1997 | |
| K913133, 09/27/1991 | ||
| Number of levels: | 3 | 3 |
| 3 | ||
| Analytes: | pH, blood gases, Na+, K+ ,Li+, Cl-, iMg++, iCa++,Glucose, Lactate, BUN,Creatinine | pH, blood gases, Na+, K+,iCa++, Cl-, Li+, iMg++, Glucose,Lactate, BUN, Creatinine, tHb,Hb derivatives and bilirubin |
| pH, blood gases, Na+, K+,Cl-, iCa++, tHb and Hbderivatives | ||
| Container: | clear, glass ampoule | clear, glass ampoule |
| Clear, glass ampoule | ||
| Fill volume: | 2.5 mL | 1.7 mL |
| 2.5 mL | ||
| Color: | Clear | Red |
| Red | ||
| Matrix: | Buffered, aqueouselectrolyte solutionequilibrated with carbondioxide and oxygen gasmixture | Buffered, aqueous electrolytesolution equilibrated withcarbon dioxide and oxygengas mixture |
| Buffered, aqueouselectrolyte solutionequilibrated with carbondioxide and oxygen gasmixture. |
* This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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(4) Description of the new device
COMBITROL PLUS B / AUTOTROL PLUS B is a specially formulated, threelevel, aqueous liquid material intended for use to monitor all analytes measured by the Roche OMNI S Analyzer. COMBITROL PLUS B / AUTOTROL PLUS B provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.
COMBITROL PLUS B / AUTOTROL PLUS B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, urea, and hematocrit, and suitable concentrations of dyes to simulate clinically relevant values of bilirubin, hemoglobin and hemoglobin derivatives: 02Hb, COHb, MetHb and HHb.
COMBITROL PLUS B / AUTOTROL PLUS B is a non-hazardous aqueous solution containing no biological materials.
- (5) Intended use of the device
COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert.
(6) Technological characteristics of the device.
This material consists of buffered aqueous electrolyte solutions with clinically relevant concentrations of the targeted analytes, tonometered with precision gas mixtures of carbon dioxide and oxygen to achieve pH and blood gas values which span the range of values typical for such products with the same intended use. A mixture of dyes is used to simulate absorbance of hemoglobin derivatives and bilirubin. Hematocrit is simulated by conductivity.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements: Real-time evaluation of products with essentially similar formulation and failure mode to support stability. Test precision
(b) (2) Summary of clinical tests submitted with the premarket notification for the device.
N/A
(b) (3) Conclusions drawn from the clinical and non-clinical trials.
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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Public Health Service
AUG 2 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen Storro Senior Director, OA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, MA 01432
K032453 Re:
Trade/Device Name: Roche COMBITROL PLUS B and Roche AUTOTROL PLUS B Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality Control Material (Assayed and Unassayed). Regulatory Class: Class I Product Code: JJY Dated: August 8, 2003 Received: August 15, 2003
Dear Ms. Storro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number: K03 2453
Device Name: Roche COMBITROL PLUS B and Roche AUTOTROL PLUS B
Indications for Use:
COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert.
For In Vitro Diagnostic Use
| Carol C. Benson & Jen Cooper, DVM |
|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K032453 |
|---|---|
| -------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
لا_ Prescription Use
OR Over-The-Counter Use ___________ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.