QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET

K961912 · Consolidated Technologies, Inc. · JJY · Aug 15, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961912
• Device Name: QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
• Applicant: Consolidated Technologies, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Clinical laboratories, performing quantitative or semi-quantitative tests to determine alpha fetoprotein (AFP) in patient specimen and desiring to use the quality control material that is not provided with the kit used for such measurement, may use Qualitrol AFP Control Set as an alternative. Compatibility among the test reagents and Qualitrol AFP Control Set needs to be established prior to such a use.

Device Story

Qualitrol AFP Control Set serves as an assayed quality control material for clinical laboratories performing AFP testing. It is intended for use as an alternative to manufacturer-provided controls. Laboratory personnel use the control to monitor the performance and accuracy of quantitative or semi-quantitative AFP assay test reagents. The device provides a reference point to verify that test systems are functioning within established parameters, thereby ensuring the reliability of patient specimen results. It is used in a clinical laboratory setting; it does not perform analysis itself but supports the quality assurance process of diagnostic test kits.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quality control material for AFP assays. Class I device (21 CFR 862.1660). No specific materials, energy sources, or software components described.

Indications for Use

Indicated for use by clinical laboratories as an alternative quality control material for quantitative or semi-quantitative alpha fetoprotein (AFP) assays when the control is not provided with the test kit. No specific patient population, age, or gender restrictions defined.

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
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

APR 23 2009

Mr. William Cone
Regulatory Affairs
Consolidated Technologies, Inc.
2170 Woodward, Suite 100
Austin, Texas 78744-1832

Re: k961912
Trade/Device Name: Qualitrol, Alpha Fetoprotein (AFP) Control Set
Regulation Number: 21 CFR 862.1660
Regulation Name: Quality control materials (assayed and unassayed)
Regulatory Class: I
Product Code: JJY
Dated: July 26, 1996
Received: July 29, 1996

Dear Mr. Cone:

This letter corrects our substantially equivalent letter of August 15, 1996.

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 (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 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

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Page 2 – Mr. William Cone

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Immunology and Hematology Devices at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K961912

Device Name: Qualitrol AFP Control Set

## Indications For Use:

Clinical laboratories, performing quantitative or semi-quantitative tests to determine alpha fetoprotein (AFP) in patient specimen and desiring to use the quality control material that is not provided with the kit used for such measurement, may use Qualitrol AFP Control Set as an alternative. Compatibility among the test reagents and Qualitrol AFP Control Set needs to be established prior to such a use.


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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

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

B