(266 days)
The Quantimetrix Dropper hsCRP High Sensivity CRP Control is intended for the quality control of laboratory testing procedures of high sensitivity C-Reactive protein (CRP). It is intended for professional in vitro diagnostic use only.
The Dropper® hsCRP Control is a ready-to-use liquid control that does not require reconstitution nor frozen storage. The product is supplied in three clinically significant levels filled to 1mL in convenient plastic dropper bottles. The controls are formulated in a human serum derived matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated with human CRP antigen to clinically significant targets that are ideal to monitor high sensitivity CRP test methods.
This document describes the Quantimetrix Dropper® hsCRP High Sensitivity CRP Control (K152117), a quality control material.
Since this is a quality control material and not a diagnostic device intended to diagnose a condition, the acceptance criteria and study details are focused on the stability and performance of the control material itself, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for algorithms that interpret medical images or data.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Quantimetrix Dropper® hsCRP High Sensitivity CRP Control
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability (Refrigerated) | Control material remains stable for the specified duration at 2-8°C. | 90 days at 2 to 8°C |
| Open Vial Stability (Room Temp) | Control material remains stable for the specified duration at room temperature (18-25°C). | 30 days at room temp. (18-25°C) |
| Shelf-life Stability (Unopened) | Control material remains stable for the specified duration at 2-8°C. | 36 months at 2 to 8°C |
| Value Assignment Ranges | Established from interlaboratory and intralaboratory data, calculating a mean value and applying a +/- 3SD range. | Values are established, and individual laboratory means should fall within the ranges listed. Each lab should establish its own ranges. |
Study Proving Acceptance Criteria:
The document states that "Accelerated stability studies were conducted to establish the open and unopened stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance criteria were met to support the product claims." Additionally, "Real time stability studies are ongoing and performed for every lot."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of evaluating diagnostic accuracy. Instead, the "testing" involves stability studies and value assignment.
- Stability Studies: The sample size for stability studies would refer to the number of control vials subjected to various storage conditions and time points. This detail is not explicitly provided in the document.
- Value Assignment: For value assignment, samples of a specific lot are submitted to "multiple laboratories and Quantimetrix laboratory" for testing across "different analyzer platforms." The sample size here relates to the number of vials per lot tested and the number of replicates performed. This specific number is not provided.
- Data Provenance: The data for value assignment comes from "interlaboratory and intralaboratory data using instrument manufacturer's reagents." The country of origin is not explicitly stated, but the submission is to the US FDA, implying testing relevant to the US market. The nature of these studies is prospective in the sense that they are specifically conducted to establish values for each lot and to determine stability.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept does not apply directly to this device, as it is a quality control material, not a diagnostic algorithm interpreting data. The "ground truth" for the control material is its assigned value, which is determined through assaying the material using established laboratory methods.
- For Value Assignment: The "experts" involved are the personnel in the "multiple laboratories and Quantimetrix laboratory" who perform the testing. Their specific qualifications are not detailed, but they are expected to be trained laboratory professionals capable of running the hsCRP assays. No specific "number of experts" is given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept typically applies to cases where multiple human readers are interpreting ambiguous medical images or data and need to reach a consensus. For a quality control material where analytical values are being determined, no formal adjudication method like 2+1 or 3+1 is mentioned or expected.
- Value Assignment: The "adjudication" is inherent in the "interlaboratory and intralaboratory data" where a mean value is calculated, and ranges are established (mean +/- 3SD). Outlier data might be identified and excluded statistically, but this is a statistical process, not a consensus among experts in the traditional sense.
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
No MRMC comparative effectiveness study was done or is applicable. This type of study evaluates the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Dropper® hsCRP High Sensitivity CRP Control is a quality control material, not an AI diagnostic algorithm, so this study type is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or is applicable. This device is a physical control material used in laboratory testing procedures. It is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the value assignment of the control material, the "ground truth" is established by:
- Analytical Measurement: The measured concentrations of hsCRP in the control material, as determined by multiple analyses using established laboratory instruments and reagents (instrument manufacturer's reagents).
- Statistical Analysis: Calculation of a mean value and a standard deviation (specifically, a +/- 3SD range) from the collected analytical data.
For stability studies, the "ground truth" is that the assayed values of the control material remain within a predefined acceptable range (e.g., within the established mean +/- 3SD) over the tested duration under specified storage conditions.
8. The sample size for the training set
This concept is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This concept is not applicable as this is not an AI/ML device that requires a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
QUANTIMETRIX CORPORATION KALYNA SNYLYK DIRECTOR, REGULATORY AFFAIRS/QUALITY ASSURANCE 2005 MANHATTAN BEACH BLVD REDONDO BEACH, CA 90278-1205, US
Re: K152117
Trade/Device Name: Dropper® hsCRP High Sensitivity CRP Control Regulation Number: 21 CFR 8862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: February 19, 2016 Received: February 22, 2016
Dear Kalyna Snylyk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K152117
Device Name Dropper hsCRP High Sensitivity CRP Control
Indications for Use (Describe)
The Quantimetrix Dropper hsCRP High Sensivity CRP Control is intended for the quality control of laboratory testing procedures of high sensitivity C-Reactive protein (CRP). It is intended for professional in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two overlapping circles in blue, with the letters 'QC' formed by the intersection of the circles. Below the circles, the word 'Quantimetrix' is written in a sans-serif font, also in blue. The logo appears to be clean and professional.
Traditional 510(k)
510(k) Summary Dropper® hsCRP High Sensitivity CRP Control
Submitter:
Ouantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278
Contact person:
Kalyna Snylyk Director Regulatory Affairs and Quality Assurance Telephone: (310) 536-0006 Fax: (310) 536-9977
Date Summary prepared:
April 15, 2016
Regulatory Information:
Product Trade name: Dropper® hsCRP High Sensitivity CRP Control Common name: Assayed CRP Control Review Panel: Clinical Chemistry Classifications: Class I, reserved Product code: JJX Regulation number: 21 CFR 862.1660
Device to which substantial equivalence is claimed
Liquicheck Cardiac Markers Plus Control LT Bio-Rad Laboratories Irvine, CA 92618-2017
510(k) number K123663
Indications For Use
The Quantimetrix Dropper® hsCRP High Sensitivity CRP Control is intended for the quality control of laboratory testing procedures of high sensitivity C-Reactive protein (CRP). It is intended for prescription in vitro diagnostic use only.
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Image /page/4/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two overlapping circles in blue, with the letters 'QC' formed within the circles. Below the circles, the word 'Quantimetrix' is written in a sans-serif font, also in blue. The logo appears to be a registered trademark, as indicated by the '®' symbol.
Description of Device
The Dropper® hsCRP Control is a ready-to-use liquid control that does not require reconstitution nor frozen storage. The product is supplied in three clinically significant levels filled to 1mL in convenient plastic dropper bottles. The controls are formulated in a human serum derived matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated with human CRP antigen to clinically significant targets that are ideal to monitor high sensitivity CRP test methods.
The blood donor units comprising the serum pool serum are screened for HBs antigen, HCV, HIV1, and HIV2, and found to be nonreactive by US FDA accepted methods.
Value Assignment
The value assignment testing is performed by submitting samples of a specific lot to be tested to multiple laboratories and Quantimetrix laboratory to be tested across different analyzer platforms. Expected values are established from interlaboratory and intralaboratory data using instrument manufacturer's reagents. Data derived from replicate analyses and are specific to each lot of product. Individual laboratory means should fall within the ranges listed. Value assignment ranges are established based on evaluation of data, calculating a mean value and applying a +/- 3SD range around the mean value. These values should be used as a guide in evaluating the performance of test methods. Each laboratory should establish its own ranges and specifications for the methods used to measure hsCRP. Variations from the published insert values may occur due to laboratory technique, changes in instrumentation and reagents, or to manufacturer's test methods.
Intended use
The Quantimetrix Dropper® hsCRP Control is an assayed quality control material used to monitor the performance of high sensitivity C-Reactive Protein (CRP) test methods.
Comparison of the New Device with the Predicate Device
The Dropper hsCRP Control claims substantial equivalence to the Liquicheck Cardiac markers Plus LT Control currently in commercial distribution (K123663). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
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Image /page/5/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two interlocking circles that form the letters 'QC' in a stylized manner. Below the circles, the word "Quantimetrix" is written in a sans-serif font.
Traditional 510(k) Table 1: Similarities and Differences between new and predicate device:
| Characteristics | Dropper hsCRP High SensitivityControl(New device) | Liquicheck Cardiac Markers PlusControl LT (Predicate DeviceK123663) |
|---|---|---|
| Similarities | ||
| Intended Use | Same | The product is intended for use as aquality control serum to monitor theprecision of laboratory testingprocedures listed in the package insert. |
| Form | Same | Liquid |
| Matrix | Same | Human Serum |
| Level | 3 Level Control | 3 Level Control |
| Differences | ||
| Storage Unopened(Shelf Life) | At 2-8°C until the expiration date (36months) | At -20 to -50° C until the expirationdate (3 years) |
| Open Vial | 90 days at 2-8°C and30 days at room temp (18-25°C) | 20 days at 2-8°C for most analytes(Thawed and Opened) |
| Form | Ready-to-Use Liquid | Frozen Liquid |
| Analyte(s) | Single Analyte –C-Reactive Protein (CRP) | Multi Analyte –Troponin ICreatine Kinase, Total (CK Total)CK-MB IsoenzymeDigitoxinC-Reactive Protein (CRP)MyoglobinN-terminal pro-Brain natriureticPeptide (NT-proBNP) |
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Image /page/6/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two overlapping circles in blue, forming a stylized "QC" monogram. Below the monogram, the word "Quantimetrix" is written in a sans-serif font, also in blue. The logo appears to be clean and professional, suggesting a company focused on quality control or measurement.
Traditional 510(k)
| Fill Volume | 1mL | 2.5 mL |
|---|---|---|
| Storage Condition | Refrigerated (2-8° C) until expirationdate | Frozen (-20° to -70°C) until expirationdate |
Statement of Supporting Data:
Accelerated stability studies were conducted to establish the open and unopened stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance criteria were met to support the product claims as follows:
| Open vial Stability: | 90 days at 2 to 8°C |
|---|---|
| Open vial stability: | 30 days at room temp. (18-25°C) |
| Shelf life Stability: | 36 months at 2 to 8°C |
Real time stability studies are ongoing and performed for every lot.
Conclusion:
Based on the performance characteristics indicated above, the Dropper hsCRP High Sensitivity CRP Control is substantially equivalent to the predicate device Liquicheck Cardiac Markers Plus Control LT reference 510(k) K123663
All supporting data is retained on file at Quantimetrix Corporation.
§ 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.