MEDICA EASYQC HEMATOCRIT CONTROL

K021924 · Bionostics, Inc. · GLK · Jun 24, 2002 · Hematology

Device Facts

• Record ID: K021924
• Device Name: MEDICA EASYQC HEMATOCRIT CONTROL
• Applicant: Bionostics, Inc.
• Product Code: GLK · Hematology
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.

Device Story

Medica EasyQC Hematocrit Control is a two-level, non-hazardous, aqueous electrolyte solution; simulates clinically relevant hematocrit concentrations via conductivity. Used in clinical laboratories to perform periodic quality control checks on the Medica EasyStat analyzer. Device provides a standardized reference to verify analytical performance; helps ensure accuracy of hematocrit measurements; supports laboratory quality assurance programs. No biological materials contained.

Clinical Evidence

No clinical data. Bench testing only, including real-time stability evaluation and precision testing.

Technological Characteristics

Buffered aqueous electrolyte solution; conductivity-based simulation of hematocrit; two-level concentration; packaged in 1.7 mL clear glass ampoules; non-hazardous; non-biological.

Indications for Use

Indicated for in vitro diagnostic use to monitor and evaluate the analytical performance of the Medica EasyStat analyzer for hematocrit measurement by conductivity in laboratory settings.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• RNA QC900 Hematocrit Control (K955630)

Submission Summary (Full Text)

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

KC021924

# BIONOSTICS

ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1972 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ، ﻭﻳﺘﺤﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ ﮐﺮ ﮐﺮ ﮨﮯ۔

## JUN 2 4 2002

# 510(k) Summary*

- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs [phone] x 220

## Date of preparation of this summary: 7 June 2002

- Device trade or proprietary name: (2) Medica EasyQC Hematocrit Control
## Device common or usual name or classification name:

Control, Hematocrit

| PRODUCT NOMENCLATURE | CLASSIFICATION | |
|----------------------|----------------|-------------------|
| | NUMBER | CLASS PANEL |
| HEMATOCRIT CONTROL | 864.8625 | GLK II HEMATOLOGY |

#### (3) Substantial Equivalence

Medica EasyQC Hematocrit Control is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:

Comparison of Medica EasyQC to predicate devices for substantial equivalency

| Characteristic | Predicate Devices | Modified Device |
|------------------------|-----------------------------------------|----------------------------------------|
| Name:<br>510(k), Date: | RNA QC900 Hematocrit Control<br>K955630 | Medica EasyQC Hematocrit |
| Number of levels: | 2 | 2 |
| Analytes: | Hematocrit | Hematocrit |
| Container: | clear, glass ampoule | clear, glass ampoule |
| Fill volume: | 1.7 mL | 1.7 mL |
| Color: | clear | Clear |
| Matrix: | Buffered, aqueous electrolyte solution | Buffered, aqueous electrolyte solution |

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

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

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

Medica EasyQC Hematocrit Control is a specially formulated, two-level, aqueous liquid material intended to monitor hematocrit measurement by the Medica EasyStat analyzer. Medica EasyQC Hematocrit Control 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.

Medica EasyQC Hematocrit Control is an electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the Medica EasyStat Analyzer.

Medica EasyQC Hematocrit Control is a non-hazardous aqueous solution containing no biological materials.

#### (5) Intended use of the device

Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.

#### (6) Technological characteristics of the device.

This material consists of buffered aqueous electrolyte solutions with conductivity to simulate clinically relevant concentrations hematocrit to span the range of values typical for such products with the same intended use.

### (b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Tests were conducted to verify specific performance requirements:

- a) Real-time evaluation of products with the same formulation and failure mode to support stability.
- b) 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.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Storro Director, Quality Assurance and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, Massachusetts 01432

JUN 2 4 2002

Re: k021924

> Trade/Device Name: Medica EasyQC Hematocrit Controls Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology QC Mixture Regulatory Class: II Product Code: GLK Dated: June 7, 2002 Received: June 11, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{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 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 Sutman

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:

Medica EasyQC Hematocrit Controls Device Name:

Indications for Use:

Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.

For In Vitro Diagnostic Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: overline;"> </span> |
|----------------------|---------------------------------------------------|----|--------------------------|---------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K021924 |
|---------------|---------|
|---------------|---------|

510(K) MEDICA EASYQC HEMATOCRIT-REVISED

Over-The-Counter Use***_***__

Image /page/4/Picture/9 description: The image contains a drawing of the number 2 enclosed in a circle. The number 2 is written in a simple, rounded style, and the circle is drawn around it, closely following the contours of the number. The drawing appears to be hand-drawn with a thick marker or pen, and the lines are bold and clear.

Page 10