(17 days)
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No
The document describes a liquid control material for laboratory analyzers and does not mention any AI or ML components.
No
The device is described as an "assayed control" intended to monitor and evaluate the analytical performance of a diagnostic analyzer, not to treat a patient.
No
This device is a control material used to monitor the performance of an analytical instrument (Roche OMNI S analyzer), not to diagnose a patient's medical condition. It is for "In Vitro Diagnostic Use," meaning it is used in conjunction with diagnostic tests, but it does not perform the diagnosis itself.
No
The device is a liquid control material intended for in vitro diagnostic use, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Intended Use: The device is intended to "monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert." This is a classic function of an in vitro diagnostic control material, used to verify the accuracy and precision of a diagnostic instrument.
- Device Description: The description details a "specially formulated, threelevel, aqueous liquid material intended for use to monitor all analytes measured by the Roche OMNI S Analyzer." This material is used in vitro (outside the body) to assess the performance of a diagnostic device.
Therefore, based on the provided information, the COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are indeed In Vitro Diagnostic devices.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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 B | |
| and | ||
| Roche AUTOTROL PLUS B | ||
| Blood Gas, Electrolyte | ||
| and 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 Hb | ||
| derivatives | ||
| 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, aqueous | |
| electrolyte solution | ||
| equilibrated with carbon | ||
| dioxide and oxygen gas | ||
| mixture | Buffered, aqueous electrolyte | |
| solution equilibrated with | ||
| carbon dioxide and oxygen | ||
| gas mixture | ||
| Buffered, aqueous | ||
| electrolyte solution | ||
| equilibrated with carbon | ||
| dioxide and oxygen gas | ||
| mixture. |
- 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)