COULTER LIN-X LINEARITY CONTROL, MODEL A81196

K100790 · Beckman Coulter, Inc. · JPK · Dec 21, 2010 · Hematology

Device Facts

• Record ID: K100790
• Device Name: COULTER LIN-X LINEARITY CONTROL, MODEL A81196
• Applicant: Beckman Coulter, Inc.
• Product Code: JPK · Hematology
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

COULTER® LIN-X Linearity Controls are intended to assess calibration and verify the reportable range of Coulter® Cellular Analysis Systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to Instructions for Use.

Device Story

COULTER® LIN-X Linearity Control consists of stabilized human blood components (WBC, RBC, HGB, PLT) at varying concentrations. Used in clinical laboratory settings to assess calibration and verify reportable ranges of Coulter® Cellular Analysis Systems. Clinicians or laboratory technicians process the control through the analyzer; results are compared against established expected ranges provided in the product labeling. This verification ensures instrument accuracy across its reportable range, supporting reliable patient diagnostic testing.

Clinical Evidence

Bench testing only. Stability of Level 6 was evaluated over shelf life on DxH™ 300 and DxH™ 300C systems. Value assignment and range determination processes were validated using specific COULTER reagents and statistical analysis.

Technological Characteristics

Stabilized human blood components. Levels 1-7. Assayed for WBC, RBC, HGB, and PLT. Used with Coulter® Cellular Analysis Systems. No electronic or software components.

Indications for Use

Indicated for use as a quality control mixture to assess calibration and verify the reportable range of Coulter Cellular Analysis Systems for WBC, RBC, HGB, and PLT parameters.

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

• COULTER® LIN-X Linearity Control (12 Levels) (K081641)

Submission Summary (Full Text)

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

K100790

# 510(k) Summary COULTER® LIN-X Linearity Control

#### 1. Submitted By:

Lourdes Coba Staff Requlatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue: M/C: 31-B06 Miami, Florida 33196-2500 Telephone: [phone] FAX: [phone]

DEC 2 1 2010

# 2. Date Submitted:

March 19, 2010

### 3. Device Name(s):

### 3.1 Proprietary Names

COULTER® LIN-X Linearity Control

## 3.2 Classification Name

Hematology quality control mixture (21 CFR § 864.8625)

### 4. Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|---------------------------------------------------|----------------------------------------------------|-----------------------|------------------|
| COULTER® LIN-X<br>Linearity Control<br>(7 Levels) | COULTER® LIN-X<br>Linearity Control<br>(12 Levels) | Beckman Coulter, Inc. | K081641 |

### 5. Description:

COULTER® LIN-X Linearity Controls are stabilized human blood components whose white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB) and platelets (PLT) concentrations span the instrument's reportable range. Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calibration and verify the reportable range.

Traditional 510(k) Submission Lin-X Linearity Control Beckman Coulter, Inc.

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

#### ે. Intended Use:

COULTER® LIN-X Linearity Controls are intended to assess calibration and verify the reportable range of Coulter® Cellular Analysis Systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to Instructions for Use.

## 7. Comparison to Predicate(s):

COULTER® LIN-X Linearity Control is essentially identical to the current LIN-X Linearity Control except that it only contains Levels 1-7 of the current product and Level 6 is additionally assayed for WBC. Levels 1-5 and Level 7 have not been modified.

#### 8. Summary of Performance Data:

| Study | Study Design | Study Results |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Open and<br>Closed Vial<br>Stability | Evaluated open and closed vial stability<br>of 3 lots of Level 6 of LIN-X Linearity<br>Control over the shelf life of the product<br>on a DxH™ 300 and DxH™ 300C<br>(pending 510(k) clearance K100489).<br>The stability of Level 1-5 and Level 7 was<br>previously cleared in K081641. | LIN-X Linearity Control<br>demonstrated<br>acceptable results. |
| Value<br>Assignment<br>Process | Value assignment of Level 6 WBC for<br>each lot of LIN-X Linearity Control is<br>determined on validated systems using<br>specific COULTER reagents. Assigned<br>Values are confirmed by multiple<br>analysis of the control product. | Established process for<br>generating assigned<br>values for LIN-X<br>Linearity Control. |
| Range<br>Determination<br>Process | The expected range for WBC on Level 6<br>was calculated by a bio-statistician based<br>upon the assigned values and expected<br>ranges of the WBC parameters from<br>Levels 1-5 and 7. | Established WBC<br>expected range for<br>Level 6 of LIN-X<br>Linearity Control. |

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Traditional 510(k) Submission Lin-X Linearity Control Beckman Coulter, Inc.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of a human figure embracing a bird.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Beckman Coulter, Inc. c/o Ms. Lourdes Coba Staff Regulatory Affairs Specialist 11800 SW 147" Avenue Miami, FL 33196

DEC 2 1 2010

Re: k100790

Trade/Device Name: COULTER® LIN-X Linearity Control Regulation Number: 21CFR§864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: December 10, 2010 Received: December 13, 2010

Dear Ms. Coba:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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

Page 2 – Ms. Lourdes Coba

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

enei m. chan

Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

# Indication for Use

510(k) Number (if known):

DEC 2 1 2010

Device Name: COULTER® LIN-X Linearity Control

Indication For Use:

COULTER® LIN-X Linearity Controls are intended to assess calibration and verify the reportable range of Coulter® Cellular Analysis Systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to Instructions for Use.

Prescription Use × (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100790