ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P

K972721 · Roche Diagnostic Systems, Inc. · JJX · Aug 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972721
• Device Name: ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Roche Hemoglobin A1c Control N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative HbA1c assays measuring HbA1c as a fraction of total Hemoglobin.

Device Story

Roche Hemoglobin A1c Control N and P are in vitro diagnostic quality control materials; used to monitor accuracy and precision of quantitative HbA1c assays; provides normal and pathological level benchmarks for HbA1c measurement as a fraction of total hemoglobin; used in clinical laboratory settings by laboratory professionals; assists in validating assay performance and ensuring reliable patient test results.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic quality control material; assayed for HbA1c levels; liquid or lyophilized form (implied by control material classification); intended for use with quantitative HbA1c assay systems.

Indications for Use

Indicated for use as assayed quality control material to monitor accuracy and precision of quantitative HbA1c assays at normal and pathological levels. Intended for clinical laboratory use.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James W. Haynes · Requlatory Affairs Associate Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771

AUG - 6 1997

Re : K972721 Roche Hemoglobin A1c Control N and P Regulatory Class: I Product Code: JJX Dated: July 18, 1997 Received: July 21, 1997

Dear Mr. Haynes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations .

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number (if known)

Device Name: Roche Hemoglobin A1c Control P

Indications for Use:

The Roche Hemoglobin A1c Control N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative HbA1c assays measuring HbA1c as a fraction of total Hemoglobin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Carol C. Bernam |
|---------------------|
| Alfred Montgomery |
| (Division Sign Off) |

(Division Sign-Off) Division of Clinical Laboratory Devices 97272 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)