(198 days)
Not Found
No
The device description details a standard immunoassay principle and analysis based on luminescence measurement, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies focus on traditional analytical validation metrics.
No.
The document describes an in vitro diagnostic immunoassay that measures C-Reactive Protein levels, which is used for evaluation of conditions associated with inflammation, not for treating them.
Yes
The "Intended Use / Indications for Use" section states that the immunoassay is "to be used for evaluation of conditions thought to be associated with inflammation," which directly indicates its purpose in diagnosing or assessing a medical condition.
No
The device description clearly details a hardware component (FastPack® Analyzer) that performs the immunoassay and measures luminescence. The software is part of a larger system that includes physical reagents and an analyzer.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals." This involves analyzing a biological sample (implied to be blood/serum/plasma based on the device description and performance studies) to provide information about a person's health status.
- Device Description: The description details a "Sandwich immunoassay principle" that measures "Endogenous CRP in a patient sample, calibrator, control, or verifier." This is a classic method used in IVD devices to detect and quantify specific substances in biological samples.
- Performance Studies: The performance studies describe testing with "serum patient samples," "blood collections from 41 volunteers processed to serum, EDTA plasma, and lithium-heparin plasma," and "Human serum samples." These are all biological samples used in in vitro diagnostic testing.
- Components: The description mentions "FastPack® High Sensitivity C-Reactive Protein Calibrators," "FastPack® High Sensitivity C-Reactive Protein Controls," and "FastPack® High Sensitivity C-Reactive Protein Verifiers." These are all components typically used with IVD assays for calibration, quality control, and verification.
- Predicate Devices: The listed predicate devices are also IVD products (reagents and controls for CRP testing).
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The FastPack® High Sensitivity C-Reactive Protein Immunoassay clearly fits this definition.
N/A
Intended Use / Indications for Use
FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use.
FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
FastPack® High Sensitivity C-Reactive Protein Control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JIT, JJX
Device Description
The FastPack® High Sensitivity C-Reactive Protein Immunoassay employs a Sandwich immunoassay principle. Endogenous CRP in a patient sample, calibrator, control, or verifier is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-CRP antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-CRP antibody linked to biotin. After incubation, immunoreacted complex (Monoclonal anti-CRP antibody-ALP conjugate and anti-CRP antibody linked to biotin reacted with CRP in the sample) is mixed with streptavidin coated paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-CRP monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N'-dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield Nmethylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of CRP in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.
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 use. Not intended for Point-of-Care use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: Precision was evaluated following the CLSI EP5-A2 guidance. Six serum patient samples with concentrations of ~0.5, 1.0, 2.0, 5.0, 7.5, and 12.5 mg/L CRP were tested in duplicate determinations in each of two runs per day on each of two FastPack® reagent lots, two FastPack® Analyzers per reagent lot, over a period of 20 days to yield 320 replicate determinations of each sample. A single FastPack® calibrator lot was utilized for all runs. Within-run, between-run, between-day, and residual components of variation were calculated as well as total imprecision using a general linear model.
Limits of blank, detection, and quantitation: The Limit of Blank (LOB), the Limit of Detection (LOD), and the Limit of Quantitation (LOQ) of the FastPack® C-Reactive Protein Immunoassay were determined according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation. The following are the limits determined: LOB = 0.005 mg/L, LOD = 0.032 mg/L, LOQ=0.063 mg/L.
Linearity: Linearity was determined following CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline. A high patient sample was intermixed with a low sample to generate 8 concentration levels each tested in triplicate determinations. Linear results were compared to 2nd and 3th order polynomial fits against a pre-specified allowable error. The linearity range was found to extend from the LOQ (0.063 mg/L) to 15.0 mg/L. Samples recovering above the range may be diluted using Sample Diluent A.
Interferences: Common substances (Bilirubin, Hemoglobin, Lipids, Human serum albumin, Transferrin, Human IgG) and exogenous substances (L-ascorbic acid, Oxaloacetic acid, Glutathione, Isoniazid, L-DOPA) were tested and found not to interfere at noted concentrations.
Cross-reactivity: Rheumatoid factor at up to 1000 U/mL and human anti-mouse IgG at up to 4 ug/mL do not cross-react. Heterophile samples up to 3641 ng/mL do not interfere.
Serum and plasma equivalence: Blood collections from 41 volunteers were processed to serum, EDTA plasma, and lithium-heparin plasma. Measurements were compared via Deming regression, showing equivalence.
Serum vs EDTA plasma: N compared = 41, Range of observations = 0.33 – 14.72 mg/L (Serum), 0.29 – 14.76 mg/L (EDTA Plasma), Absolute bias = -0.225 mg/L, % Bias = -6.1, Slope = 0.94, y-intercept = 0.0, R = 0.984, R2 = 0.967.
Serum vs Lithium-Heparin plasma: N compared = 41, Range of observations = 0.33 - 14.72 mg/L (Serum), 0.31 – 14.86 mg/L (Lithium-Heparin Plasma), Absolute bias = 0.002 mg/L, % Bias = 0.5, Slope = 1.00, y-intercept = 0.00, R = 0.993, R2 = 0.986.
Expected Values/Reference Intervals: A reference interval study employing serum samples from 211 subjects yielded a non-parametric 2.5th - 97.5th percentile of 0.2 - 11.4 mg/L. Mean (SD) = 3.2 (3.1) mg/L, Median (Min - Max) = 1.9 (0.2 - 13.1) mg/L.
Method Comparison: Human serum samples (N = 131) were tested with the FastPack® High Sensitivity C-Reactive Protein Immunoassay and compared to the predicate method. The FastPack® method correlated well with the predicate method. Range of observations = 0.21 to 15.0 mg/L. Correlation coefficient (R) = 0.99 (95% CI: 0.99 - 0.99), slope = 0.98 (95% CI: 0.95-1.02), and y-intercept = -0.12 mg/L (95% CI: -0.23 to 0.00).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the 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 a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
QUALIGEN, INC. MICHAEL POIRIER SENIOR VICE PRESIDENT, CSO/CTO 2042 CORTE DEL NOGAL CARLSBAD CA 92011
January 7, 2015
Re: K141689
Trade/Device Name: Fastpack High Sensitivity C-reactive Protein Immunoassay Fastpack High Sensitivity C-reactive Protein Calibrator Kit Fastpack High Sensitivity C-reactive Protein Controls, Fastpack High Sensitivity C-reactive Protein Method Verification Kit Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: II Product Code: DCK, JIT, JJX Dated: December 15, 2014 Received: December 18, 2014
Dear Mr. Poirier:
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 (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) K141689
Device Name
FastPack® High Sensitivity C-Reactive Protein Immunoassay, FastPack® High Sensitivity C-Reactive Protein Calibrator Kit, FastPack® High Sensitivity C-Reactive Protein Controls . High Sensitivity C-Reactive Protein Method Verification Kit
Indications for Use (Describe)
FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use.
FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
FastPack® High Sensitivity C-Reactive Protein Control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
4
REVISED 510(k) SUMMARY
This 510(k) Summary information is submitted in accordance with the requirements of 21 CFR § 807.92.
510(k) Number: K141689
Submitter:
Qualigen, Inc. 2042 Corte Del Nogal, Suite B Carlsbad, CA 92009
| Telephone: | (760) 918-9165 |
|---|---|
| Facsimile: | (760) 918-9127 |
Contact Person:
Mr. Michael Poirier Senior Vice President, Chief Scientific & Technical Officer Telephone: (760) 918-9165 x227 Facsimile: (760) 918-9127 Email: mpoirier@qualigeninc.com
Device Identification
| Trade Names: | FastPack® High Sensitivity C-Reactive Protein Immunoassay |
|---|---|
| FastPack® High Sensitivity C-Reactive Protein Calibrator Kit | |
| FastPack® High Sensitivity C-Reactive Protein Controls | |
| FastPack® High Sensitivity C-Reactive Protein Method | |
| Verification Kit |
Common Names: C-reactive protein Assay C-reactive protein Calibrator C-reactive protein Controls C-reactive protein Verifiers
- Classification names: Immunological Test Systems Calibrator Quality control material (assayed and unassayed)
Classifications: Class II (assay)
5
| Class II (calibrators) | |
|---|---|
| Class I, reserved (controls) | |
| Class I, reserved (verifiers) | |
| Panel: | Chemistry (75) |
| Product Codes: | DCK - C-Reactive Protein, Antigen, Antiserum |
| JIT - Calibrator, Secondary | |
| JJX - Quality control material (Assayed and Unassayed) | |
| Regulation Numbers: 21 CFR § 866.5270 - C-reactive protein immunological test system | |
| 21 CFR § 862.1150 - Calibrator | |
| 21 CFR § 862.1660 - Quality control material (Assayed and | |
| Unassayed) |
Devices to Which Substantial Equivalence is Claimed
Olympus CRP Latex reagent Olympus America, Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA K051564
Liquichek™ Cardiac Markers Plus Control Bio-Rad Laboratories 4000 Alfred Nobel Drive Hercules, CA 94547 K050537
VITROS Chemistry Products hsCRP Performance Verifier I, II, and III Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101 K041799
Device Description
The FastPack® High Sensitivity C-Reactive Protein Immunoassay employs a Sandwich immunoassay principle. Endogenous CRP in a patient sample, calibrator, control, or verifier is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-CRP antibody covalently linked to alkaline
6
phosphatase (ALP) and a different monoclonal anti-CRP antibody linked to biotin. After incubation, immunoreacted complex (Monoclonal anti-CRP antibody-ALP conjugate and anti-CRP antibody linked to biotin reacted with CRP in the sample) is mixed with streptavidin coated paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-CRP monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N'-dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield Nmethylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of CRP in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.
Intended Use
FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy The FastPack® High Sensitivity C-Reactive Protein Immunoassay is individuals. intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use.
FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
FastPack® High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.
7
| Comparison of new nevice to preated devices | |||
|---|---|---|---|
| CHARACTERISTIC | Qualigen FastPack® High | Olympus America, Inc. CRP | |
| Sensitivity C-Reactive Protein | Latex reagent | ||
| Immunoassay | K051564 | ||
| Intended Use/ | FastPack® High Sensitivity C- | Olympus System Reagent and | |
| Indications for Use | Reactive Protein Immunoassay is | calibrators for the quantitative | |
| to be used for evaluation of | determination of C-Reactive | ||
| conditions thought to be associated | Protein on OLYMPUS | ||
| with inflammation, in otherwise | Analyzers. Measurement of | ||
| healthy individuals. The | CRP is useful for the detection | ||
| FastPack® High Sensitivity C- | and evaluation of infection, | ||
| Reactive Protein Immunoassay is | tissue injury, inflammatory | ||
| intended for use with the | disorders, and associated | ||
| FastPack® Analyzer. Not intended | |||
| for Point-of-Care use. | diseases. Measurements may | ||
| also be used as an aid in the | |||
| identification of individuals at | |||
| risk of future cardiovascular | |||
| disease. High sensitivity CRP | |||
| (hsCRP) measurements, when | |||
| used in conjunction with | |||
| traditional clinical laboratory | |||
| evaluation of acute coronary | |||
| syndromes, may be useful as an | |||
| independent marker of prognosis | |||
| for recurrent events, in patients | |||
| with stable coronary disease or | |||
| acute coronary syndromes. | |||
| Sample Type | Serum or plasma | ||
| (EDTA | |||
| or | Same | ||
| lithium heparin) | |||
| Sample Preparation | Standard processing for serum or | Same | |
| plasma | |||
| Interpretation of | Standard Curve | Same | |
| Results | |||
| Reagent Storage | 2-8 °C | Same | |
| Temperature | |||
| Testing Environment | Professional use | Same | |
| Precision (% CV) | Within-run: ≤ 1.0% | Within-run: ≤ 3.2% | |
| Between-run: ≤ 5.2% | Total: ≤ 3.8% | ||
| Total: ≤ 9.0% | |||
| Linearity | Assay linear from 0.2 to 15.0 mg/L | Assay linear from 0.2 - 160 mg/L | |
| in High Sensitivity Application | |||
| Interfering | No interference from high levels of | No interference from high levels | |
| Substances/Specificity | conjugated bilirubin, unconjugated | of bilirubin, hemoglobin, and | |
| hemoglobin, | |||
| bilirubin, | triglycerides | ||
| triglycerides. | |||
| human | |||
| serum | |||
| L-ascorbic | |||
| albumin, | |||
| acid. | |||
| oxaloacetic | |||
| acid, | |||
| glutathione, | |||
| L-DOPA; no | |||
| isoniazid, | |||
| and - | |||
| from | |||
| rheumatoid | |||
| interference | |||
| factor, human anti-mouse IgG, and | |||
| Comparative Testing vs | |||
| Established Methods | transferrin | ||
| FastPack® vs. Olympus AU2700 | |||
| N = 131 | |||
| Range of observations: | |||
| 0.21 to 15.0 mg/L | |||
| Deming regression: | |||
| Slope (95% CI): 0.98 (0.95-1.02) | |||
| y (95% CI): -0.12 (-0.23 to 0.00) | |||
| R (95% CI) = 0.99 (0.99-0.99) | |||
| Sy\x = 0.629 | AU400 vs. AU640 | ||
| N = 109 | |||
| Range of observations: | |||
| 0.28-147.2 mg/L | |||
| Deming regression: | |||
| Slope = 1.025 | |||
| y = -0.022 | |||
| R = 0.999 | |||
| Expected | |||
| Values/Reference | |||
| Intervals | 0.2 - 11.4 mg/L | Cardiac risk assessment | |
| categories: | |||
| Low 3.0 mg/L |
Comparison of new device to predicate devices
8
Differences between FastPack® and Olympus High-Sensitivity C-Reactive Protein
| Assays | ||
|---|---|---|
| CHARACTERISTIC | Qualigen FastPack® | |
| High-Sensitivity C-Reactive | ||
| Protein Immunoassay | Olympus America, Inc. CRP | |
| Latex reagent | ||
| K051564 | ||
| Methodology | The FastPack® High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific monoclonal antibodies. | The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. |
| Assay principle | Chemiluminescence | Turbidimetry |
| Assay procedure | Automated | Automated |
| Approximate assay time | 8 minutes | 3.5 minutes |
| Assay range | 0.2 - 15.0 mg/L in High Sensitivity Application | 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) |
| Traceability | Traceable to the ERM-DA474/IFCC reference which serves as the Primary Reference Material | “…traceable to an external standard.” (K051564 510(k) Decision Summary) |
9
| CHARACTERISTIC | Qualigen FastPack®
High-Sensitivity C-
Reactive Protein
Immunoassay | Olympus America, Inc. CRP
Latex reagent
K051564 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indication for Use | For in-vitro diagnostic
use in calibrating
FastPack® High-
Sensitivity C-Reactive
Protein Immunoassay | Olympus System Reagent and
calibrators for the quantitative
determination of C-Reactive
Protein on Olympus Analyzers. |
| Antigen used in calibrators | Human CRP | Same |
| Matrix | Liquid human serum
matrix containing a
predetermined level of
human CRP | Liquid human serum matrix
containing predetermined levels of
human CRP |
| Storage temperature | 2-8 °C | Same |
Similarities between FastPack® and Olympus CRP Calibrators
Differences between FastPack® and Olympus CRP Calibrators
| CHARACTERISTIC | Qualigen FastPack®
High-Sensitivity C-
Reactive Protein
Immunoassay | Olympus America, Inc. CRP
Latex reagent
K051564 |
|-----------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Number of calibrators | 1 | 5 (additional calibrators provided
at higher concentrations to enable
CRP measurements in the “Normal
Application”) |
10
| CHARACTERISTIC | Qualigen FastPack®
High-Sensitivity C-Reactive
Protein Immunoassay | Bio-Rad Laboratories
Liquichek™ Cardiac
Markers Plus Control
K050537 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indication for Use | For in-vitro diagnostic use to
monitor the precision and
accuracy of the FastPack®
High-Sensitivity C-Reactive
Protein Immunoassay on the
FastPack® Analyzer. | Liquichek™ Cardiac
Markers Plus Control are
intended for use as quality
control serum to monitor
the precision of laboratory
testing procedures listing in
the package insert. |
| Antigen used in controls | Human CRP | B-type Natriuretic Peptide,
Creatine Kinase (Total), C-
Reactive Protein,
Homocysteine, Digitoxin,
N-terminal pro-B-type
Natriuretic Peptide, CK-
MB, Myoglobin, Troponin
I, Troponin T |
| Matrix | Liquid human serum matrix
containing a predetermined
level of human CRP | Prepared from human
serum with added
constituents of human and
animal origin,
preservatives, and
stabilizers. The controls are
in liquid form. |
| Storage temperature | 2-8 °C | 2-8 °C (Opened), or -20 to -
70 °C (Unopened) |
Similarities between FastPack® and Predicate Controls
Differences between FastPack® and Predicate Controls
| CHARACTERISTIC | Qualigen FastPack®
High-Sensitivity C-Reactive
Protein Immunoassay | Bio-Rad Laboratories
Liquichek™ Cardiac
Markers Plus Control
K050537 |
|------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Number of levels | 2 | 3 |
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| CHARACTERISTIC | Qualigen FastPack®
High-Sensitivity C-Reactive
Protein Immunoassay | Ortho-Clinical
Diagnostics, Inc. VITRO
Chemistry Products
hsCRP Performance
Verifier, I, II, and III
K041799 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indication for Use | For use in the quantitative
verification of calibration and
assay range of the quantitative
FastPack® High-Sensitivity C-
Reactive Protein Immunoassay
on the FastPack® Analyzer. | VITROS hsCRP
Performance Verifiers are
assayed controls to monitor
performance of hsCRP
Reagent on VITROS 5,1 FS
Chemistry Systems |
| Antigen used | Human CRP | Same |
| Storage temperature | 2-8 °C | Same |
| Matrix | Low Verifier: HEPES buffer
with Bovine Serum Albumin
(BSA) and Detergent
(Cremophor A25)
Mid and High Verifiers: Liquid
human serum matrix containing
a predetermined level of human
CRP | A base matrix of human
plasma proteins to which
stabilizers and preservative
have been added. |
| Number of levels | 3 | Same |
Similarities between FastPack® CRP Verifiers and Predicate Verifiers
Performance Summary
Precision
Precision was evaluated following the CLSI EP5-A2 guidance. Six serum patient samples with concentrations of ~0.5, 1.0, 2.0, 5.0, 7.5, and 12.5 mg/L CRP were tested in duplicate determinations in each of two runs per day on each of two FastPack® reagent lots, two FastPack® Analyzers per reagent lot, over a period of 20 days to yield 320 replicate determinations of each sample. A single FastPack® calibrator lot was utilized for all runs. Within-run, between-run, between-day, and residual components of variation were calculated as well as total imprecision using a general linear model. The table below presents the results:
12
| Within-Run | Between-Run | Between-Day | Residual | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Overall Mean | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Serum Sample 1 | 0.38 | 0.002 | 0.53 | 0.014 | 3.68 | 0.005 | 1.32 | 0.029 | 7.74 | 0.033 | 8.68 |
| Serum Sample 2 | 1.00 | 0.004 | 0.43 | 0.038 | 3.80 | 0.013 | 1.30 | 0.077 | 7.71 | 0.087 | 8.70 |
| Serum Sample 3 | 2.06 | 0.008 | 0.39 | 0.071 | 3.45 | 0.030 | 1.46 | 0.162 | 7.89 | 0.180 | 8.74 |
| Serum Sample 4 | 5.01 | 0.023 | 0.46 | 0.206 | 4.11 | 0.073 | 1.46 | 0.288 | 5.74 | 0.362 | 7.23 |
| Serum Sample 5 | 7.67 | 0.035 | 0.46 | 0.314 | 4.09 | 0.111 | 1.45 | 0.596 | 7.78 | 0.684 | 8.92 |
| Serum Sample 6 | 12.54 | 0.073 | 0.58 | 0.649 | 5.18 | 0.230 | 1.83 | 0.843 | 6.72 | 1.091 | 8.70 |
Limits of blank, detection, and quantitation
The Limit of Blank (LOB), the Limit of Detection (LOD), and the Limit of Quantitation (LOQ) of the FastPack® C-Reactive Protein Immunoassay were determined according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation. The following are the limits determined:
LOB = 0.005 mg/L LOD = 0.032 mg/L LOQ=0.063 mg/L
Linearity
Linearity was determined following CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline. A high patient sample was intermixed with a low sample to generate 8 concentration levels each tested in triplicate determinations. Linear results were compared to 2nd and 3th order polynomial fits against a pre-specified allowable error. The linearity range was found to extend from the LOQ (0.063 mg/L) to 15.0 mg/L. Samples recovering above the range may be diluted using Sample Diluent A.
Interferences
The following substances normally present in blood were tested and found not to interfere in the FastPack® High Sensitivity C-Reactive Protein Immunoassay at the noted concentrations:
| Bilirubin (conjugated) | Tested to 40 mg/dL |
|---|---|
| Bilirubin (unconjugated) | Tested to 40 mg/dL |
| Hemoglobin | Tested to 750 mg/dL |
| Lipids | Tested to 1000 mg/dL |
13
Human serum albumin Transferrin Human IgG
Tested to 7.7 g/dL Tested to 567 mg/dL Tested to 2961 ug/mL
The following exogenous substances potentially present in blood were tested and found not to interfere in the FastPack® High Sensitivity C-Reactive Protein Immunoassay at the noted concentrations:
| L-ascorbic acid | Tested to 200 mg/dL |
|---|---|
| Oxaloacetic acid | Tested to 300 μΜ |
| Glutathione | Tested to 300 μΜ |
| Isoniazid | Tested to 300 μΜ |
| L-DOPA | Tested to 300 μΜ |
Cross-reactivity
Rheumatoid factor at up to 1000 U/mL and human anti-mouse IgG at up to 4 ug/mL do not cross-react in the FastPack® High Sensitivity C-Reactive Protein Immunoassay. Additionally, heterophile samples with activity up to 3641 ng/mL do not interfere in the assay.
Serum and plasma equivalence
Blood collections were obtained from 41 volunteers and processed in parallel to serum, EDTA plasma, and lithium-heparin plasma. Measurements in FastPack® High Sensitivity C-Reactive Protein Immunoassay were compared via Deming regression and indicated equivalence between the three matrices.
| Parameter | Result |
|---|---|
| N compared | 41 |
| Range of observations, mg/L | Serum: 0.33 – 14.72 |
| EDTA Plasma: 0.29 – 14.76 | |
| Absolute bias, mg/L | -0.225 |
| % Bias | -6.1 |
| Deming regression results | |
| Slope | 0.94 |
| y-intercept | 0.0 |
| R | 0.984 |
| R2 | 0.967 |
Serum versus EDTA plasma
14
| Parameter | Result |
|---|---|
| N compared | 41 |
| Range of observations, mg/L | Serum: 0.33 - 14.72 |
| Lithium-Heparin Plasma: 0.31 – 14.86 | |
| Absolute bias, mg/L | 0.002 |
| % Bias | 0.5 |
| Deming regression results | |
| Slope | 1.00 |
| y-intercept | 0.00 |
| R | 0.993 |
| R2 | 0.986 |
Serum versus lithium-heparin plasma
Expected Values/Reference Intervals
A reference interval study employing serum samples from 211 subjects representing 4 different geographic regions of the United States yielded the results in the table below. The non-parametric 2.5th - 97.5th percentile of 0.2 - 11.4 mg/L provides the reference interval determined from this study.
| Observed values | |
|---|---|
| Mean (SD) | 3.2 (3.1) mg/L |
| Median (Min - Max) | 1.9 (0.2 - 13.1) mg/L |
| 2.5th - 97.5th percentile | 0.2 - 11.4 mg/L |
Newborns with no evidence of infection have CRP concentrations of