(115 days)
No
The device description details a standard immunoturbidimetric assay with calculations based on a pre-programmed calibration curve stored on an RFID card. There is no mention of adaptive learning, pattern recognition beyond simple absorbance measurement, or any other characteristics typically associated with AI/ML. The "SMART" in the analyzer name appears to refer to its compact size and pre-programmed nature, not AI capabilities.
No
Explanation: The device is an in vitro diagnostic (IVD) test kit used to measure C-reactive protein for the detection and evaluation of inflammatory disorders, infection, and tissue injury. It does not provide treatment or directly alleviate a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP)... For in vitro diagnostic use only." It also mentions its use for "detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury," which falls under diagnostic purposes.
No
The device is a test kit that includes reagents, controls, and an RFID card, all of which are physical components. It also requires a separate hardware analyzer (SMART Analyzer) to function. While the RFID card contains software/data (calibration curve, timing), the overall system is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states: "The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers." The phrase "in vitro quantitative determination" is a key indicator of an IVD.
- Purpose: The intended use describes the measurement of CRP in human samples to aid in the "detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury." This is a diagnostic purpose performed outside of the body.
- "For in vitro diagnostic use only": This phrase is explicitly stated in both the Test Kit and Control Set descriptions.
- Device Description: The description details a laboratory-based assay (latex enhanced immunoturbidimetric assay) performed on a specific analyzer using human whole blood samples.
- Control Set: The inclusion of a control set for quality control of the assay further supports its use in a diagnostic setting.
All of these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP POC Control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.
Product codes
DCK, JJX
Device Description
Diazyme's hsCRP POC Test Kit is based on a latex enhanced immunoturbidimetric assay on Diazyme's SMART analyzer. Agglutination occurs when an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles. This agglutination is detected as an absorbance change (700 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The instrument calculates the CRP concentration of patient specimen by use of a lot specific calibration curve that is stored in an RFID card provided with each hsCRP POC kit. The RFID card is inserted in the SMART analyzer and is needed for every single run.
Diazyme hsCRP POC Control Kit is intended for use as quality controls for the Diazyme hsCRP POC Test Kit and is packaged separately. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. OC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme hsCRP POC Test Kit system thus consists of the following:
- hsCRP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- hsCRP POC Control Kit. Controls are provided for quality control of the hsCRP POC Assay.
Equipment needed for Diazyme hsCRP POC Test Kit:
- SMART Analyzer (K092911).
Kit components (Candidate device):
Reagent 1: 40 DRS cuvette (prefilled) - 100 mM TrisCl buffer
Reagent 2: 40 DRS caps (prefilled) - Suspension of anti-human CRP polyclonal antibody coated latex particles (= 0.95.
Key Results: Slope = 0.9871, Intercept = -0.4004, Correlation coefficient = 0.9511. Range of values: 0.47-22.50.
(2) External method comparison:
Study Type: Method comparison at three (3) POL sites by intended users.
Sample Size: One hundred and twenty (120) paired human whole blood-serum samples initially; 116 used after excluding four samples outside assay detection range.
Data Source: Whole blood samples tested on SMART analyzers; corresponding plasma specimens tested on Hitachi 917 with predicate device (K103557) at Diazyme Laboratories.
Acceptance Criteria: Slope = 0.90~1.10; r2 >= 0.95.
Key Results: Combined results for 3 POL Sites - Slope = 0.9712, Intercept = -0.0870, Correlation coefficient = 0.9836. Range of values: 0.47-22.79.
Expected value/Reference range:
Study Type: Verification of transferability of reference interval from predicate device according to CLSI C28-A3.
Sample Size: 150 apparently healthy male and female individuals aged >= 18 years.
Key Results: Expected normal range verified:
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
|C|21558
510(k) SUMMARY
SEP 2 7 2012 Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| USA | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4762 | |
| Fax: 858-455-2120 | |
| abhijit.datta@diazyme.com | |
| Name of the Device: | Diazyme hsCRP POC Test Kit; Diazyme hsCRP POC |
| Control Kit | |
| Manufacturing Address | Diazyme Laboratories |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| USA | |
| Establishment Registration | 2032900 |
Executive Summary
Detailed performance characteristics and comparison analysis are given in this filing that demonstrates substantial equivalence of the hsCRP POC Assay Kit to predicate device that is currently being marketed. The performance characteristics of the hsCRP POC Assay Kit are substantially similar to that of the approved predicate device (K103557). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the hsCRP POC Assay and offers POL users an in vitro diagnostic device system to measure CRP in human venous whole blood samples.
1
Intended Use:
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP POC Control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.
Device Description:
Clinical Significance
CRP (C-reactive protein) is an acute phase protein whose concentration is seen to increase as a result of the inflammatory process, most notably in response to pneumococcal (bacterial) infectious, histolytic disease and a variety of disease states. Originally discovered by Tillet et al. in 1930 in patient sera with acute infection. CRP has now come to be used as a marker or general diagnostic indicator of infections and inflammation, in addition to serving as a monitor of patient response to therapy and surgery. Furthermore, regular measurements of CRP in infants can be a useful aid in the early diagnosis of infectious disease.
Assav Principle
Diazyme's hsCRP POC Test Kit is based on a latex enhanced immunoturbidimetric assay on Diazyme's SMART analyzer. Agglutination occurs when an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles. This agglutination is detected as an absorbance change (700 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The instrument calculates the CRP concentration of patient specimen by use of a lot specific calibration curve that is stored in an RFID card provided with each hsCRP POC kit. The RFID card is inserted in the SMART analyzer and is needed for every single run.
Diazyme hsCRP POC Control Kit is intended for use as quality controls for the Diazyme hsCRP POC Test Kit and is packaged separately. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. OC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Re-
2
agent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme hsCRP POC Test Kit system thus consists of the following:
- hsCRP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- hsCRP POC Control Kit. Controls are provided for quality control of the . hsCRP POC Assay.
Equipment needed for Diazyme hsCRP POC Test Kit:
| • SMART Analyzer (K092911). |
|---|
| Kit components |
(Candidate device)
Reagent 1
40 DRS cuvette (prefilled)
- · 100 mM TrisCl buffer
Reagent 2
40 DRS caps (prefilled)
- Suspension of anti-human CRP polyclonal antibody coated latex particles . ( Trade Name: Diazyme high sensitivity C-reactive protein (hsCRP) POC Test kit and Diazyme high sensitivity C-reactive protein (hsCRP) POC control kit Regulation Number: 21 CFR $866.5270
Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Codes: DCK, JJX Dated: August 7, 2012 Received: August 9, 2012
Dear Dr. Datta:
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 11 you atent 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 Four may 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,
Courney 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
510(k) Number: K121558
Device Name: Diazyme high sensitivity C-reactive protein (hsCRP) POC Test kit and Diazyme high sensitivity C-reactive protein (hsCRP) POC control set.
Indications for Use:
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP POC control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) '
Rude Chale
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
£121558 510(K)
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