(266 days)
Not Found
No
The device description and performance studies focus on the stability and formulation of a laboratory control material, with no mention of AI or ML technologies.
No
The device is a quality control product for laboratory testing procedures of high sensitivity C-Reactive protein, not a device for treating or diagnosing a medical condition in a patient.
No
This device is a control for laboratory testing procedures, not a diagnostic device itself. It is used to monitor the quality of high sensitivity C-Reactive protein (CRP) test methods, which are diagnostic tests.
No
The device description clearly states it is a "ready-to-use liquid control" supplied in "plastic dropper bottles," indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "It is intended for professional in vitro diagnostic use only."
- Purpose: The device is a quality control for laboratory testing procedures of high sensitivity C-Reactive protein (CRP). Quality controls are essential components of in vitro diagnostic testing to ensure the accuracy and reliability of the results.
- Device Description: The description details a product used in a laboratory setting to monitor test methods, which aligns with the nature of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional in vitro diagnostic use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines that form the head and body.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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.
5
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 Sensitivity
Control
(New device) | Liquicheck Cardiac Markers Plus
Control LT (Predicate Device
K123663) |
|----------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Same | The product is intended for use as a
quality control serum to monitor the
precision of laboratory testing
procedures 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 (36
months) | At -20 to -50° C until the expiration
date (3 years) |
| Open Vial | 90 days at 2-8°C and
30 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 I
Creatine Kinase, Total (CK Total)
CK-MB Isoenzyme
Digitoxin
C-Reactive Protein (CRP)
Myoglobin
N-terminal pro-Brain natriuretic
Peptide (NT-proBNP) |
6
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 expiration | |
| date | Frozen (-20° to -70°C) until expiration | |
| date |
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.