R&D RET-LINE KIT

K013898 · R&D Systems, Inc. · JPK · Jan 22, 2002 · Hematology

Device Facts

• Record ID: K013898
• Device Name: R&D RET-LINE KIT
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the linearity of automated hematology analyzers for reticulocyte parameter determinations.

Device Story

R&D RET-LINE is a multi-level quality control product consisting of human and mammalian erythrocytes suspended in simulated plasma fluid with preservatives. Packaged in 3.0 mL glass vials with silicon rubber closures. Used in clinical laboratory settings to verify the linearity of automated hematology analyzers for reticulocyte counts. The product mimics human whole blood, allowing laboratory personnel to assess instrument performance across a range of reticulocyte percentages. By confirming the analyzer's linear response, the device ensures the accuracy of patient reticulocyte measurements. It is intended for single use per vial.

Clinical Evidence

Bench testing only. Validation performed on three lots to assess stability and linearity. Product met all acceptance criteria for remaining within assay ranges over the 75-day closed-vial shelf life when stored at 2-8 °C.

Technological Characteristics

Multi-level suspension of human and mammalian erythrocytes in simulated plasma fluid with preservatives. Packaged in 3.0 mL glass vials with silicon rubber closures. Non-electronic, chemical/biological control reagent. No software or connectivity.

Indications for Use

Indicated for use as a multi-level linearity control to verify the linear operation of automated hematology analyzers for reticulocyte parameter determinations.

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 (K000115)

Submission Summary (Full Text)

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## JAN 2 2 2002

K013898

## 510(k) Summary R&D Systems, Inc. RET-LINE

| Date of Summary: | December 13, 2001 |
|----------------------|-----------------------------------------------------------------------|
| Company Name: | R&D Systems, Inc.<br>614 McKinley Place N.E.<br>Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp<br>612-656-4413, FAX [phone] |
| Classification name: | Hematology quality control mixture |
| Product name: | R&D RET-LINE |
| CFR section: | 864.8625 Hematology quality control mixture |

Device Class:

Predicate Device: Retic Chex Linearity, manufactured by Streck Laboratories, 14306 Industrial Rd. Omaha, NE 68144. 510(k) number: K000115

Class II

Description: R&D RET-LINE is a multi-level suspension of human erythrocytes and mammalian erythrocytes suspended in a simulated plasma fluid with preservatives packaged in a glass vial with a silicon rubber closure containing 3.0 mL of reagent.

Intended use: R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the linearity of automated hematology analyzers for reticulocyte parameter determinations.

Comparison with Predicate Device: R&D RET-LINE and Retic Chex Linearity are multi-level devices intended for verification of reticulocyte analysis on a variety of automated hematology instruments. Both contain stabilized human red blood cells and simulated human reticulocytes that properly mimic human whole blood on the intended use analyzers. Both cover a range of reticulocyte percentages that model reportable patient ranges and both comprise a true linearity and can be used to verify the linear operation of the intended hematology analyzers.

Discussion: Nonclinical testing of three validation lots focused on the performance attributes of stability and linearity assessment. R&D RET-LIN passed the acceptance criteria of remaining within the assay ranges over the life of the product. R&D RET-LINE also met linearity specifications. Expiration dating has been established at 75 days (closed vial) when stored at 2 - 8 °C and handled according to instructions for use. Normal use of this product is to use it once and discard any leftover product, therefore, is no open vial stability claim.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-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 symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ralph E. Hogancamp Quality Specialist R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413

Re: K013898

Trade/Device Name: R&D RET-LINE Kit Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: January 10, 2002 Received: January 11, 2002

Dear Mr. Hogancamp:

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.

JAN 2 2 2002

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.

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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 nredicate 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 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

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Device Name: R&D RET-LINE Kit

Indications for Use:

R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the IteeD 1011 Direct is a matology analyzers for reticulocyte parameter determinations.

Josephine Bautista

n S n SyrFord Laboratory Devices 013898 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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Over-The-CounterUse__

(Optional Format 1-2-96)

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