HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

K073178 · R&D Systems, Inc. · JPK · Dec 27, 2007 · Hematology

Device Facts

• Record ID: K073178
• Device Name: HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Dec 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

HCT Extended is a control designed to monitor values obtained from automated, semiautomated and manual methods. Please refer to the for specific instrument models.

Device Story

HCT Extended Hematology Control; in-vitro diagnostic reagent; human erythrocytes in plasma-like fluid with preservatives. Used as quality control material to monitor hematocrit measurement performance. Sampled like patient specimen; processed via automated, semi-automated, or manual hematology methods. Provides stable reference values to verify diagnostic test accuracy; helps laboratories detect instrument calibration shifts or performance degradation. Supplied in two levels (Abnormal I and II) in 3.0 mL vials.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility testing across three lots yielded average CV < 5%. Value assignment performed using HemataSTAT II, Microhematocrit Centrifuge, and Sysmex XE-2100. Stability validated for 21 days (open vial) and 75 days (closed vial) at 2-8°C.

Technological Characteristics

In-vitro diagnostic reagent; human erythrocytes in plasma-like fluid with preservatives. Two levels (Abnormal I and II). 3.0 mL vial form factor. Storage 2-8°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an assayed laboratory control to monitor the performance of diagnostic tests for hematology, specifically hematocrit, using automated, semi-automated, or manual methods.

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

• R&D Systems CBC-7 Hematology Control (K843962)

Submission Summary (Full Text)

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

K073178

# 510(k) Summary

#### Submitter Information

R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

Contact: Nancy Ring Phone: [phone] Fax: [phone]

DEC 2 7 2007

Date Prepared: 11/12/07

#### Device Information

Proprietary Name: HCT Extended Control Common Name: Hematology Controls Classification 21 CFR 864.8625 Classification Name: Hematology Quality Control Mixture Product Code: JPK Device Class: -Hematology (81) Panel:

## Predicate Device

R&D Systems CBC-7 Hematology Control (K843962)

#### Description of Device

HCT Extended Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes suspended in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods. It is sampled in the same manner as a patient specimen.

## Intended Use:

HCT Extended is a control designed to monitor values obtained from automated, semiautomated and manual methods. Please refer to the for specific instrument models.

## Technological Comparison to Predicate

The new device has the same technological characteristics and intended use as the legally marketed predicate device. Both products are used to monitor values from automated, semi-automated and manual methods. Both are assayed controls that can be used to monitor hematocrit.

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

# Summary of Performance Data

Laboratory testing of 3 validation lots has shown the HCT Extended Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The HCT Extended Hematology Control passed the acceptance criteria of remaining within the assay range over the stated life of the product.

# Substantial Equivalence Conclusion

The data demonstrates that the HCT Extended Hematology Control is substantially equivalent to the legally marketed predicate device.

{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 consists of a stylized graphic of a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the graphic. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

DEC 2 7 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

R & D Systems, Inc. C/O Nancy C. Ring 614 McKinley Place, N.E. Minneapolis, MN 55413

Re: k073178

Trade/Device Name: HCT Extended Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: November 12, 2007 Received: November 13, 2007

Dear Ms. Ring:

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. Ilsting 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 mav 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.

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

Page 2 -

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,

Peter 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

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

Page 3 --

.

:

cc: HFZ-401 DMC

HFZ-404 510(k) Staff HFZ- 440 Division D.O.

{5}------------------------------------------------

R & D Systems, Inc. HCT Extended Hematology Control November 12, 2007

# Indications for Use

510(k) Number (if known): __ KO 73/ 9 8

Device Name: HCT Extended Hematology Control

Indications for Use:

It is an established laboratory procedure to use a stable control to monitor the performance of diagnostic tests. HCT Extended Hematology Control is an assayed control designed to monitor values obtained from automated, semi-automated and manual methods.

For in vitro Diagnostic Use Only

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Josephine Bautista
Division Sign-Off

e of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073178

Page 1 of 1 ..