(24 days)
Cliniqa 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.
Cliniqa Beta HCG Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Control a ready-to-use liguid control requiring no reconstitution or frozen storage.
Cliniqa Beta HCG Calibration Verification Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Calibration Verification Control a ready-to-use liquid control requiring no reconstitution or frozen storage.
Here's an analysis of the acceptance criteria and study information for the Cliniqa Beta HCG Control and Cliniqa Beta HCG Calibration Verification Control, based on the provided text:
Based on the provided K121237 510(k) summary, the device is a Quality Control Material (Assayed and Unassayed) for Beta HCG assays, not a diagnostic algorithm or image analysis device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of device submission.
The submission focuses on the performance characteristics relevant to a quality control material, primarily value assignment and stability.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device as a quality control material, the "acceptance criteria" are implied by the successful establishment of value assignment and stability claims.
| Acceptance Criteria (Implied for QC Material) | Reported Device Performance |
|---|---|
| Value Assignment Accuracy | The Mean and Expected Range for each method shall be presented in each lot-specific insert. These values are derived from analysis of vials representative of the entire lot, averaged from raw data. The Expected Range combines estimates of assay variance from participating laboratory data and other studies. This information is provided as a guide for laboratories. |
| Shelf-Life Stability | Cliniqa Beta HCG Control Level 1,2,3:- Accelerated Stability: Performed at 45°C and 37°C, supporting an initial claim of 3.6 years at 2-8°C.- Real-time Stability: Ongoing testing at 2-8°C to support a claim of 3 years.Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, 3:- Accelerated Stability: Performed at 45°C and 37°C, supporting an initial claim of 3.6 years at 2-8°C.- Real-time Stability: Ongoing testing at 2-8°C to support a claim of 3 years. |
| Open-Vial Stability | Cliniqa Beta HCG Control Level 1, 2, 3: Real-time testing supports a claim of 30 days stability at 2-8°C once opened.Cliniqa Beta HCG Calibration Verification Control Level 1, 2, 3: Real-time testing supports a claim of 30 days stability at 2-8°C once opened. |
| Traceability | Traceability is dependent on the manufacturer of the reagents used for value assignment. Specifically, calibration of the Roche Elecsys HCG plus Beta reagent is standardized against the 4th International Standard for Chorionic Gonadotropin from the National Institute of Biological Standards and Control (NIBSC) code 75/589. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size in the context of typical "test set" for a diagnostic algorithm. For value assignment, it mentions "analysis of vials representative of the entire lot." For stability, it refers to "real-time and accelerated stability tests" and "real-time testing." The number of vials or measurements
is not detailed. - Data Provenance: Not specified as country of origin. The "participating laboratory data" for value assignment suggests multi-site input, but locations are not given. The traceability to NIBSC is an international standard.
- Retrospective or Prospective: Stability studies are typically prospective (real-time testing) and the accelerated tests are also designed to predict future stability. Value assignment would be done concurrently for each lot.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this device type. This is a quality control material where "ground truth" refers to the established values and stability claims, primarily determined through laboratory testing and reference to international standards.
4. Adjudication method for the test set
Not applicable. The "ground truth" for this device is based on analytical measurements and adherence to established scientific and manufacturing practices for quality control materials, not expert consensus on interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a quality control material, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
The "ground truth" for this product type is established through:
- Analytical Measurement: The mean and expected range for each lot are determined by averaging raw data obtained for each method using specific reagents and calibrators.
- Traceability to International Standards: The calibration of the Roche Elecsys HCG plus Beta reagent (used for value assignment) is standardized against the 4th International Standard for Chorionic Gonadotropin from NIBSC (code 75/589).
- Validated Stability Protocols: Real-time and accelerated stability study protocols determine the shelf-life and open-vial claims.
8. The sample size for the training set
Not applicable. This is a quality control material, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
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510(k) Summary
MAY 1 8 2012
:
| Cliniqa Corporation288 Distribution StreetSan Marcos, CA 92078 |
|---|
| Proprietary name: Cliniqa Beta HCG Control Level 1,2,3Common name: Quality Control Material (Assayed and Unassayed)Classification: Class I, ReservedProduct Code: JJX |
| Proprietary name: Cliniqa Beta HCG Calibration Verification Control LevelsCommon name: Quality Control Material (Assayed and Unassayed)Classification: Class I, ReservedProduct 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 andpurified human antigens. Preservatives and stabilizers have been addedto maintain product integrity. CLINIQA Beta HCG Control a ready-to-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 fromhuman serum and purified human antigens. Preservatives and stabilizers .have been added to maintain product integrity. CLINIQA Beta HCGCalibration Verification Control a ready-to-use liquid control requiringno 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 Level1,2,3 | Cliniqa LiquidQC hCG ControlLevel 1, Cliniqa LiquidQC hCG | |
| Cliniqa Beta HCG CalibrationVerification Controls, Level 1,2,3. | Control Level 2, CliniqaLiquidQC hCG Control Level 3, | |
| IntendedUse: | Cliniqa Beta HCG Control Level 1,Cliniqa Beta HCG Control Level 2,Cliniqa Beta HCG Control Level3, are assayed quality controlmaterials used to monitor theprecision of Beta HCG assays | CLINIQA LiquidQC Control isintended for use as an assayedquality control material forquantitative Human ChorionicGonadotropin analysis. |
| Cliniqa Beta HCG CalibrationVerification Controls, Levels 1, 2,and 3 are assayed quality controlmaterials used to monitor theprecision of Beta HCG assays. | CLINIQA LiquidQC Control isintended for use as an assayedquality control material forquantitative Human ChorionicGonadotropin analysis. | |
| Matrix | Human serum with added buffer,stabilizers, and purified humanhormones. | Human plasma and humanhormones. Preservatives,stabilizers, and sodium azidehave been added. |
| Form | Liquid | Liquid |
| Open VialStability | 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°CShelf Life: 3 years at 2-8°C | Opened: 30 days at 2-8°CShelf Life: 3 years at 2-8°C |
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| PerformanceCharacteristics | The Cliniqa Beta HCG Control Level 1,2,3 and the Cliniqa Beta HCGCalibration Verification Controls, Levels 1, 2, 3 was evaluated for valueassignment and stability. See the following sections for details. |
|---|---|
| Traceability | Traceability is dependent on the manufacturer of the reagents used for valueassignment. Calibration of the Roche Elecsys HCG plus Beta reagent isstandardized against the 4th International Standard for ChorionicGonadotropin from the National Institute of Biological Standards andControl (NIBSC) code 75/589. |
| ValueAssignment | The Mean and Expected Range for each method shall be presented in eachlot-specific insert of Cliniqa Beta HCG Controls and Calibration VerificationControls. The indicated values shall be derived from analysis of vialsrepresentative of the entire lot. The raw data obtained for each method shallbe averaged to obtain the Mean. The Expected Range of the Mean shall bedetermined by combining estimates of assay variance as determined byparticipating laboratory data and other currently available studies.The Expected Range of the Mean is provided to assist the laboratory until ithas established its own mean and standard deviation. The indicated Meanand Expected Range of the Mean is provided to serve only as a guide inassessing the performance of test method in laboratories.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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Page 2
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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or (301) 796-5680 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)
Page 1 of 1
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.