(132 days)
No
The description focuses on standard immunological and turbidimetric measurement principles, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is an in-vitro diagnostic device used to measure C-reactive protein, which aids in the diagnosis and monitoring of inflammatory diseases, rather than providing direct therapeutic intervention.
Yes
The device aids in the diagnosis and monitoring of inflammatory diseases by measuring C-reactive protein (CRP), which helps in evaluating the amount of inflammatory injury.
No
The device is described as a "benchtop C-Reactive Protein Immunological Test System" and measures CRP levels by reacting anti-CRP antibody coated latex particles with lyzed blood and determining the rate of the turbidimetric reaction in the near infrared spectrum. This clearly indicates a physical instrument with hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "aiding in diagnosis and monitoring of inflammatory diseases" by "measuring CRP on anti-coagulated whole blood samples" and "serum samples." This involves testing samples taken from the human body in vitro (outside the body) to provide information for diagnosis and monitoring.
- Device Description: The device is described as a "benchtop C-Reactive Protein Immunological Test System" that measures CRP on "Whole Blood and Serum samples in-vitro." This directly aligns with the definition of an in vitro diagnostic device.
- Predicate Device: The predicate devices listed are "C-reactive protein immunological test system" and "IMMUNOCHEMISTRY SYSTEM," which are also IVD devices used for measuring substances in body fluids.
The core function of the device is to analyze biological samples (whole blood and serum) outside of the body to provide diagnostic information, which is the defining characteristic of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible.
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 inflammatory injury to body tissues.
Product codes
DCN
Device Description
The Paros CRP is a benchtop C-Reactive Protein Immunological Test System. It is a single parameter instrument (CRP only), with the ability to measure CRP on Whole Blood and Serum samples in-vitro. It employs the same measurement principles as the CRP measurement module of the ABX / Horiba ™MICROS CRP (K002646, October 2000). The Paros CRP does not have a cell counting module.
The CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lyzed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The determination of substantial equivalence is based on precision, linearity, stability and carry-over studies as well as an inter-procedural correlation study.
The data presented in this 510K Pre-market Notification demonstrate good precision as assessed by NCCLS EP5-A. Total Imprecision ranged from between 0 and 2.6 CV%.
Accuracy / bias assessment (NCCLS EP 9-A) showed no evidence of significant bias. Good correlation was demonstrated between the Paros CRP and the Beckman Immage for Whole Blood (R2=0.99). Similarly, the correlation for Serum samples between the Paros CRP and the Beckman Immage was excellent (R =0.98). For Whole blood samples, the linear regression formula of the trend line was Y-0.92X + 0.03. A comparison of the serum results showed linear regression trend line formula of: Y=0.95X.
Linearity assessment data supports a Whole Blood CRP linearity claim from 0.2 to 10 mg/d1; and for Serum samples, a linearity range between 0.2 and 7 mg / dl is supported.
The data shows linearity across the tested range for Whole Blood (Paros CRP result = 1.05 X Expected Target CRP value) R2=0.99; and serum: (Paros CRP result = 0.9X Expected Target CRP value) Re = 0.98.
The Sample Stability Study showed reproducibility of results over the entire 72 hour assessment period. At a level of 0.2 mg / dl, the % difference in results can be attributed to the fact that there is a single decimal point on the CRP result, and to the level of CRP testing. All other results showed
§ 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
DEC 2 3 2002
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: KO 32690
- ABX Diagnostics Company: 34 Bunsen Drive Irvine CA92618 USA Phone: (949)-453-0500 Fax: (949)-453-0600 Contact Person: Ian Giles Date Prepared: May 20, 2002
Paros CRP Trade Name:
Common Name: In Vitro Diagnostic C-Reactive Protein Immunological Test System
Classification Name: C-Reactive Protein Immunological Test System
Device Classification: Class II
Regulation Number: 21 CFR (866.5270)
Substantial Equivalence:
The Paros CRP is substantially equivalent to the following devices:
- ABX / Horiba ™ MICROS CRP (K002646 October 2000) .
- Beckman Coulter Immage IMMUNOCHEMISTRY SYSTEM . (K981638 June 1998).
Description:
The Paros CRP is a benchtop C-Reactive Protein Immunological Test System. It is a single parameter instrument (CRP only), with the ability to measure CRP on Whole Blood and Serum samples in-vitro. It employs the same measurement principles as the CRP measurement module of the ABX / Horiba ™MICROS CRP (K002646, October 2000). The Paros CRP does not have a cell counting module.
The CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lyzed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
1
Indications for Use:
The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible.
Discussion of Performance Data Summary:
The determination of substantial equivalence is based on precision, linearity, stability and carry-over studies as well as an inter-procedural correlation study.
The data presented in this 510K Pre-market Notification demonstrate good precision as assessed by NCCLS EP5-A. Total Imprecision ranged from between 0 and 2.6 CV%.
Accuracy / bias assessment (NCCLS EP 9-A) showed no evidence of significant bias. Good correlation was demonstrated between the Paros CRP and the Beckman Immage for Whole Blood (R2=0.99). Similarly, the correlation for Serum samples between the Paros CRP and the Beckman Immage was excellent (R =0.98). For Whole blood samples, the linear regression formula of the trend line was Y-0.92X + 0.03. A comparison of the serum results showed linear regression trend line formula of: Y=0.95X.
Linearity assessment data supports a Whole Blood CRP linearity claim from 0.2 to 10 mg/d1; and for Serum samples, a linearity range between 0.2 and 7 mg / dl is supported.
The data shows linearity across the tested range for Whole Blood (Paros CRP result = 1.05 X Expected Target CRP value) R2=0.99; and serum: (Paros CRP result = 0.9X Expected Target CRP value) Re = 0.98.
The Sample Stability Study showed reproducibility of results over the entire 72 hour assessment period. At a level of 0.2 mg / dl, the % difference in results can be attributed to the fact that there is a single decimal point on the CRP result, and to the level of CRP testing. All other results showed ✓ |
|----------------------|----------------------------------------------------------------|
| (Per 21 CFR 801.109) | |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | J. Reeve for J. Bautista |
|---|---|
| Division of Clinical Laboratory Devices |
| 510(k) Number | KC022690 |
|---|---|
| --------------- | ---------------------------------------------------------- |