RETIC-CHEX LINEARITY FOR BC

K070199 · Streck · JPK · Feb 23, 2007 · Hematology

Device Facts

• Record ID: K070199
• Device Name: RETIC-CHEX LINEARITY FOR BC
• Applicant: Streck
• Product Code: JPK · Hematology
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Retic-Chex Linearity for BC is an assayed linearity control kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

Device Story

Retic-Chex Linearity for BC is a quality control material consisting of stabilized human red blood cells and simulated human reticulocytes in 3.0 mL plastic vials. It provides five levels of reticulocyte percentage (0% to 29.5%) to verify the linearity and accuracy of automated hematology analyzers. Used in clinical laboratory settings by laboratory technicians to satisfy regulatory requirements (CAP/CLIA) for verifying patient reportable ranges. The healthcare provider runs the control material through the hematology instrument; the instrument measures the reticulocyte percentage; the provider compares the instrument's output against the assay sheet values to ensure the system is performing within specified accuracy limits. This verification ensures the reliability of patient reticulocyte counts, aiding in the diagnosis and monitoring of hematological conditions.

Clinical Evidence

Bench testing only. Three studies were conducted: 1) Run-to-run reproducibility and comparison to whole blood; 2) Long-term stability; 3) Open vial stability. Results demonstrated consistent reproducibility, stability for the entire product dating, and substantial equivalence to the predicate device.

Technological Characteristics

Stabilized human red blood cells and simulated human reticulocytes in polypropylene vials. Multi-level control (5 levels). Storage: 2–10°C. Stability: 105 days closed, 5 days open. Standard referenced: NCCLS H38-P.

Indications for Use

Indicated for use as an assayed linearity control kit to assess accuracy and verify reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

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

• Retic-Chex Linearity (Streck)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck<br>7002 South 109 ^th Street<br>Omaha, NE 68128 |
|-------------------------|------------------------------------------------------------------|
| Official Correspondent: | Carol Thompson<br>Quality Assurance Manager<br>[phone] |
| Date Prepared: | January 19, 2007 |
| | FEB 2 3 2007 |
| Names of Device: | |
| Trade Name: | Retic-Chex ^® Linearity for BC |
| Common Name: | Hematology Linearity Material |
| Classification Name: | Hematology quality control mixture (§ 864.8625) |

#### Predicate Devices:

Retic-Chex Linearity manufactured by Streck

#### Description:

Retic-Chex Linearity for BC is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials, containing 3.0 mL volumes. The device consists of five levels of reticulocyte percentage range from 0 to 29.5%. Closures are injection molded polypropylene screw top caps. The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assay sheet.

### Intended Use:

Retic-Chex Linearity for BC is an assayed linearity control kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

#### Comparison with Predicate Devices:

| | Predicate - Retic-Chex Linearity | Product - Retic-Chex Linearity for<br>BC |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Closed Vial<br>Stability | 105 days | 105 days |
| Open Vial Stability | 5 days | 5 days |
| Intended Use | Retic-Chex Linearity is a multi level<br>calibration (linearity) assessment kit for<br>reticulocyte counting. It is designed for<br>use on the following instruments: Bayer<br>Advia 120, Sysmex R-3000, Sysmex<br>XE-2100, and Abbott Cell-Dyn 4000.<br>Use of this kit allows users to satisfy<br>CAP requirements and CLIA<br>recommendations to verify patient<br>reportable ranges. | Retic-Chex Linearity for BC is an<br>assayed linearity control kit, which<br>can be used to assess the<br>instrument's accuracy and to verify<br>patient reportable ranges of<br>automated and semi-automated<br>hematology instrumentation capable<br>of enumerating reticulocytes. |
| Formulation | | Same formula as Retic-Chex<br>Linearity. The only difference is the<br>way the retics are processed. |
| Storage<br>Conditions | 2 - 10°C | 2 - 10°C |
| Level 1 range | 0.4% - 1.1% | 0.4% - 1.1% |
| Level 2 range | 4.4% - 5.6% | 4.7% - 6.8% |
| Level 3 range | 8.6% - 10.0% | 9.5% - 12.0% |
| Level 4 range | 12.7% - 14.4% | 14.2% - 17.2% |
| Level 5 range | 23% - 25% | 26.5% - 29.5% |

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## Discussion of Tests and Test Results:

Three studies of Retic-Chex Linearity for BC were conducted:

I) Run to Run Reproducibility and Comparison to Whole Blood; II) Long Term Stability; and III) Open Vial Stability. Study results showed Retic-Chex Linearity for BC to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.

### Conclusions Drawn From Tests:

Study results show Retic-Chex Linearity for BC to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. Retic-Chex Linearity for BC is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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## 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 consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# STRECK

C/O Kerrie Oetter 7002 South 109th Street Omaha, Nebraska 68128

FEB 2 3 2007

Re: k070199

Trade/Device Name: Retic-Chex Linearity for BX Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: January 19, 2007 Received: January 22, 2007

Dear Ms. Oetter:

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Robert M. Becker

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K070199 510(k) Number (if known):

Retic-Chex® Linearity for BC Device Name:

Indications For Use:

Retic-Chex Linearity for BC is an assayed linearity kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE on another Page if needed)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

K070199