MODIFICATION TO RAICHEM CALCIUM REAGENT

K022049 · Hemagen Diagnostics, Inc. · CJY · Jul 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022049
• Device Name: MODIFICATION TO RAICHEM CALCIUM REAGENT
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Jul 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).

Device Story

Raichem Calcium Reagent is an in vitro diagnostic reagent used to measure calcium levels in serum and heparinized plasma samples. It is intended for use in clinical laboratory settings by trained laboratory personnel. The reagent facilitates the quantitative determination of calcium, which assists clinicians in diagnosing and monitoring conditions such as parathyroid disease, bone disorders, chronic renal disease, and tetani. The output is a calcium concentration value, which informs clinical decision-making regarding patient metabolic and endocrine health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for calcium measurement. Chemical assay principle. Intended for use with clinical chemistry analyzers.

Indications for Use

Indicated for in vitro diagnostic measurement of calcium in serum and heparinized plasma to aid in diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and tetani.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a series of three abstract human figures or birds in flight, rendered in black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 9 2002

Mr. Jose A. Montanez Corporate Director, QA/RA Official Correspondent Hemagen® Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045

k022049 Re:

> Trade/Device Name: Raichem® Calcium Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: June 21, 2002 Received: June 24, 2002

Dear Mr. Montanez:

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.

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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 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 i 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/cdch/dsmaldsmamain.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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## Attachment 2

## INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: RAICHEM® Calcium Reagent

Indications For Use: RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
| OR | |
| Over-The-Counter-Use | |

| (Division Sign-Off) | |
|---------------------|-------------|
| | Jean Cooper |

Division of Clinical Laboratory Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________