COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3

K012431 · Bionostics, Inc. · JJY · Aug 28, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012431
• Device Name: COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
• Applicant: Bionostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

COMBITROL TS / AUTOTROL TS assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI, alpha series instruments for the analytes listed in the package insert.

Device Story

COMBITROL TS and AUTOTROL TS are aqueous liquid multi-analyte controls used for quality assurance in clinical laboratories. The device contains a stable suspension of polystyrene microbeads that reflect and absorb red and infrared light, simulating the optical properties of erythrocytes to allow for the measurement of total hemoglobin (tHb), hematocrit, and oxygen saturation (SO2) in the same manner as whole blood. The controls are provided in three levels with varying microbead concentrations to simulate low, medium, and high hematocrit samples. The device also contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, lithium, ionized magnesium, urea, glucose, lactate, and creatinine. Laboratory personnel use these controls to perform periodic quality control checks on Roche OMNI, alpha series analyzers to ensure analytical performance and detect systematic deviations.

Clinical Evidence

No clinical data. Bench testing only. Stability claims are supported by accelerated aging studies on labile analytes and historical experience with similar formulations.

Technological Characteristics

HEPES-based aqueous liquid control; contains polystyrene microbeads for optical simulation of erythrocytes (tHb, hematocrit, SO2). Three-level concentration format. Packaged in 1.7 mL glass ampoules. Designed for use with Roche OMNI, alpha series analyzers.

Indications for Use

Indicated for use in clinical laboratories as a quality control product for Roche OMNI, alpha series instruments to evaluate test precision and detect systematic analytical deviations for analytes listed in the package insert.

Regulatory Classification

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.

Predicate Devices

• COMBITROL PLUS Multi-Analyte Control (K972868, K913133)
• AVL OPTI-check PLUS Multi-Analyte Control (K001632)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 2 8 2001

Ko 12431

# 510(k) Summary*

BIONOSTICS

- Submitter's name, address (a) (1) Bionostics, Inc. 2 Craig Road Acton, MA 10720
Contact Person Kathleen Storro Director, QA & Regulatory Affairs [phone] x 220

Date of preparation of this summary: 27 July 2001

- (2) Device trade or proprietary name:
COMBITROL TS and AUTOTROL TS Multi Analyte Controls

## Device common or usual name or classification name:

Multi Analyte Control Solution, All Types (Assayed and Unassayed)

| PRODUCT NOMENCLATURE | CLASSIFICATION<br>NUMBER | CLASS | PANEL |
|--------------------------------|--------------------------|-------|-----------|
| MULTI ANALYTE CONTROL SOLUTION | 862.1660 75 JJY | I | CHEMISTRY |

#### Substantial Equivalence (3)

COMBITROL TS and AUTOTROL TS Multi Analyte Controls are substantially equivalent in function, safety and efficacy to a number of currently marketed devices known as 'Combi' or 'Multi-Analyte' control solutions. In example:

Comparison of COMBITROL TS / AUTOTROL TS to predicate devices for substantial equivalency

| Characteristic | Predicate Devices | Modified Device | |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Name: | COMBITROL PLUS<br>Multi-Analyte Control | AVL OPTI-check PLUS<br>Multi-Analyte Control | COMBITROL TS<br>AUTOTROL TS<br>Multi Analyte Controls |
| 510(k), Date: | K972868, 08/28/97<br>K913133, 09/27/91 | K001632, 06/19/00 | |
| Number of levels: | 3 | 3 | 3 |
| Analytes: | pH, PCO2, PO2, Na+,<br>K+, Cl-, iCa++<br>Li+, iMg++, tHb, Hb<br>derivatives, Urea,<br>Glucose, Lactate,<br>Creatinine | pH, PCO2, PO2, Na+, K+,<br>Cl-, iCa++, Urea, Glucose<br>tHb, SO2 | pH, PCO2, PO2, Na+, K+,<br>Cl-, iCa++, Li+, iMg++, tHb,<br>Hct, SO2, Urea, Glucose,<br>Lactate, Creatinine, |
| Container: | glass ampoule | glass ampoule | glass ampoule |
| Fill volume: | 1.7 mL | 1.7 mL | 1.7 mL |
| Color: | red | milky | milky |
| Matrix: | HEPES based aqueous<br>with dyes to simulate<br>Hb and derivatives | HEPES based aqueous<br>with polystyrene beads to<br>simulate Hb and SO2 | HEPES based aqueous<br>with polystyrene beads to<br>simulate Hb and SO2 |

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

{1}------------------------------------------------

#### Description of the new device (4)

Description of the new device
COMBITROL TS / AUTOTROL TS is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the Roche OMNI, alpha series analyzers. It contains a stable suspension of polystyrene microbeads which series and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the Roche OMNI, alpha series analyzers. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. metobeaus to simulate tons in the provide 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 TS / AUTOTROL TS contain clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, lithium, ionized 1 002, 1 02, 80drains) lactate, urea, creatinine and suitable concentrations of microbeads to simulate clinically relevant values of tHb, hematocrit and oxygen saturation.

- Intended use of the device (5)
COMBITROL TS / AUTOTROL TS assayed controls are intended to be used to Combilition 10 / 110 / 110 / 110 / 110 Roche OMNI, alpha series instruments for the analytes listed in the package insert ..

- Technological characteristics of the device. (6)
Technological characteribaTS assayed control is intended to be used to monitor and evaluate the analytical performance of the Roche OMNI, alpha series instruments for the analytes listed in the package insert is technologically equivalent to currently marketed products to which substantial equivalence is claimed. It contains a low concentration, stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb, hematocrit and SO2 in exactly the same manner as these analytes are determined in whole blood by the Roche OMNI, alpha series instruments.

- Summary of non-clinical tests submitted with the premarket notification for the (b) (1) device.
Accelerated aging studies on most labile analytes, together with experience with other products with similar formulations support stability claim.

- Summary of clinical tests submitted with the premarket notification for the device. (b) (2) N/A
- Conclusions drawn from the clinical and non-clinical trials. (b) (3) Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 8 2001

Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics, Inc. 2 Craig Road Acton, MA 01720

Re: K012431

Trade/Device Name: COMBITROL TS / AUTOTROL TS Multi-Analyte Controls Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJS, JJY Dated: July 27, 2001 Received: July 31, 2001

Dear Ms. Storro:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 are gone an other 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 regulations (1 recultures) in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perious on. Failure to comply with the GMP regulation may result in regulatory 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 regulations.

{3}------------------------------------------------

Page 2 -

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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

{4}------------------------------------------------

# 510(k) Number: K012431

### COMBITROL TS / AUTOTROL TS Device Name: Multi-Analyte Controls

COMBITROL TS / AUTOTROL TS assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI, alpha series instruments for the analytes listed in the package insert.

For In Vitro Diagnostic Use

## Indications for Use:

As a part of the quality control program in institutions reporting those analytes listed in the package insert, COMBITROL TS and AUTOTROL TS Multi-Analyte Controls should be used in Roche OMNI, alpha series instruments to evaluate test precision and to detect systematic analytical deviations in those laboratories choosing to use a traditional, liquid, quality control product.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div></div> |
|------------------------------------------|-------------|
|------------------------------------------|-------------|

OR

| (Division Sign-Off) | Kesia Alexander for Jan Cooper (Optional Format 1-2-96) |
|-----------------------------------------|---------------------------------------------------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K012431 |