BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE

K121237 · Cliniqa Corporation · JJX · May 18, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121237
• Device Name: BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
• Applicant: Cliniqa Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Cliniqa Beta HCG Control Level 1, Cliniqa Beta HCG Control Level 2, Cliniqa Beta HCG Control Level 3, are assayed quality control materials used to monitor the precision of Beta HCG assays. Cliniga Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.

Device Story

Assayed quality control materials; human serum-based with purified human antigens, stabilizers, and preservatives. Used to monitor precision of Beta HCG assays. Ready-to-use liquid form; no reconstitution or freezing required. Used by laboratory personnel to verify assay performance; provides mean and expected range for specific lots. Stability: 3 years shelf life at 2-8°C; 30-day open-vial stability at 2-8°C. Benefits patient by ensuring accuracy and reliability of clinical Beta HCG test results.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including value assignment studies and real-time/accelerated stability testing to support shelf-life and open-vial claims.

Technological Characteristics

Liquid quality control material; human serum matrix with added buffers, stabilizers, and purified human hormones. Storage at 2-8°C. Value assignment derived from representative lot analysis using reagents and calibrators standardized against NIBSC 75/589.

Indications for Use

Indicated for use as assayed quality control materials to monitor the precision of Beta HCG assays in clinical laboratory settings.

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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K121237

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# 510(k) Summary

MAY 1 8 2012

:

| Cliniqa Corporation<br>288 Distribution Street<br>San Marcos, CA 92078 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name: Cliniqa Beta HCG Control Level 1,2,3<br>Common name: Quality Control Material (Assayed and Unassayed)<br>Classification: Class I, Reserved<br>Product Code: JJX |
| Proprietary name: Cliniqa Beta HCG Calibration Verification Control Levels<br>Common name: Quality Control Material (Assayed and Unassayed)<br>Classification: Class I, Reserved<br>Product Code: JJX |
| CLINIQA Liquid QC hCG Control, Levels 1, 2, 3 (k022232) . |
| Cliniqa Beta HCG Control Level 1, 2, 3 |
| CLINIQA Beta HCG Control is prepared from human serum and<br>purified human antigens. Preservatives and stabilizers have been added<br>to maintain product integrity. CLINIQA Beta HCG Control a ready-to-<br>use liguid control requiring no reconstitution or frozen storage. |
| Cliniqa Beta HCG Calibration Verification Control Levels 1,2,3 |
| CLINIQA Beta HCG Calibration Verification Control is prepared from<br>human serum and purified human antigens. Preservatives and stabilizers .<br>have been added to maintain product integrity. CLINIQA Beta HCG<br>Calibration Verification Control a ready-to-use liquid control requiring<br>no reconstitution or frozen storage. |
| 1, 2, 3 |

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Intended use

Cliniqa Beta HCG Control Level 1, Cliniqa Beta HCG Control Level 2, Cliniqa Beta HCG Control Level 3, are assayed quality control materials used to monitor the precision of Beta HCG assays

Cliniga Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.

### Comparison Table

·

| Item | DEVICE: | PREDICATE (k022232) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cliniqa Beta HCG Control Level<br>1,2,3 | Cliniqa LiquidQC hCG Control<br>Level 1, Cliniqa LiquidQC hCG |
| | Cliniqa Beta HCG Calibration<br>Verification Controls, Level 1,2,3. | Control Level 2, Cliniqa<br>LiquidQC hCG Control Level 3, |
| Intended<br>Use: | Cliniqa Beta HCG Control Level 1,<br>Cliniqa Beta HCG Control Level 2,<br>Cliniqa Beta HCG Control Level<br>3, are assayed quality control<br>materials used to monitor the<br>precision of Beta HCG assays | CLINIQA LiquidQC Control is<br>intended for use as an assayed<br>quality control material for<br>quantitative Human Chorionic<br>Gonadotropin analysis. |
| | Cliniqa Beta HCG Calibration<br>Verification Controls, Levels 1, 2,<br>and 3 are assayed quality control<br>materials used to monitor the<br>precision of Beta HCG assays. | CLINIQA LiquidQC Control is<br>intended for use as an assayed<br>quality control material for<br>quantitative Human Chorionic<br>Gonadotropin analysis. |
| Matrix | Human serum with added buffer,<br>stabilizers, and purified human<br>hormones. | Human plasma and human<br>hormones. Preservatives,<br>stabilizers, and sodium azide<br>have been added. |
| Form | Liquid | Liquid |
| Open Vial<br>Stability | 30 days | 30 days |
| Limitations | Not Applicable | Contains Sodium Azide |
| Caution | Human Source Material | Human Source Material |
| Values | Specific for each lot | Specific for each lot |
| Stability | Opened: 30 days at 2-8°C<br>Shelf Life: 3 years at 2-8°C | Opened: 30 days at 2-8°C<br>Shelf Life: 3 years at 2-8°C |

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| Performance<br>Characteristics | The Cliniqa Beta HCG Control Level 1,2,3 and the Cliniqa Beta HCG<br>Calibration Verification Controls, Levels 1, 2, 3 was evaluated for value<br>assignment and stability. See the following sections for details. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Traceability | Traceability is dependent on the manufacturer of the reagents used for value<br>assignment. Calibration of the Roche Elecsys HCG plus Beta reagent is<br>standardized against the 4th International Standard for Chorionic<br>Gonadotropin from the National Institute of Biological Standards and<br>Control (NIBSC) code 75/589. |
| Value<br>Assignment | The Mean and Expected Range for each method shall be presented in each<br>lot-specific insert of Cliniqa Beta HCG Controls and Calibration Verification<br>Controls. The indicated values shall be derived from analysis of vials<br>representative of the entire lot. The raw data obtained for each method shall<br>be averaged to obtain the Mean. The Expected Range of the Mean shall be<br>determined by combining estimates of assay variance as determined by<br>participating laboratory data and other currently available studies.<br><br>The Expected Range of the Mean is provided to assist the laboratory until it<br>has established its own mean and standard deviation. The indicated Mean<br>and Expected Range of the Mean is provided to serve only as a guide in<br>assessing the performance of test method in laboratories.<br><br>Assignment of values shall be performed using the reagents, calibrators, and |

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#### Stability

Real-time and accelerated stability tests were conducted to establish the shelflife and open-vial claims.

Shelf Life of the Cliniqa Beta HCG Control Level 1,2,3 is 3 years at 2-8°C Shelf Life of the Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, 3 is 3 years at 2-8ºC.

#### Open-Vial Stability

Real-time testing was performed and the data support the package insert claim that the Cliniqa Beta HCG Control Level 1, 2, 3 is stable up 30 days at 2-8°C once opened.

#### Open-Vial Stability

Real-time testing was performed and the data support the package insert claim that the Cliniqa Beta HCG Calibration Verification Control Level 1, 2, 3 is stable up 30 days at 2-8℃ once opened.

#### Shelf-Life Stability:

The accelerated stability testing performed at 45℃ and 37℃ supports an initial shelf-life claim of 3.6 years at 2-8°C. For the Cliniqa Beta HCG Control Level 1, 2, 3 Real-time testing at 2-8°C is on-going to support a claim of 3 years.

The accelerated stability testing performed at 45°C and 37°C supports an initial shelf-life claim of3.6 years at 2-8°C. For the Cliniqa Beta HCG Calibration Verification Control Level 1, 2, 3 Real-time testing at 2-8℃ is on-going to support a claim of 3 years.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Cliniqa Corporation c/o Dawn Gast 288 Distribution Street San Marcos. CA 92078

MAY 1 8 2012

Re: k121237

Trade Name: Cliniqa Beta HCG Control Level 1, 2, 3

Cliniga Beta HCG Calibration Verification Controls Levels 1, 2, 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Codes: JJX Dated: April 23, 2012 Received: April 24, 2012

Dear Ms. Gast:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): K12/237

Device Name:

Cliniga Beta HCG Control Level 1,2 ,3

Cliniqa Beta HCG Calibration Verification Controls Levels 1, 2, 3

Indications for Use:

Cliniga Beta HCG Controls, Levels 1, 2, and 3 and Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.

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)

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

KIZIZ37 510(K)

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