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

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 . (< 0.5%).
Calibrator

1 x preprogrammed lot specific RFID card in each kit

Control Set

l x 1.0 mL Control 1

l x 1.0 mL Control 2

AI/ML Overview

The document describes the Diazyme hsCRP POC Test Kit, an in vitro diagnostic device for quantitative determination of C-reactive protein (CRP) in human venous whole blood. The device is intended for the detection and evaluation of inflammatory disorders, associated diseases, infection, and tissue injury.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines several performance tests with specific acceptance criteria and the observed results.

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Precision (Internal)	Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices)	Within Run CV%:- 0.813 mg/L: 9.62%- 3.186 mg/L: 2.83%- 12.560 mg/L: 1.79%Total Precision CV%:- 0.813 mg/L: 8.17%- 3.186 mg/L: 3.09%- 12.560 mg/L: 2.12%
Precision (External)	Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices)	Within Run CV% (POL sites):- 0.798 mg/L: 4.67%- 4.796 mg/L: 7.02%- 0.758 mg/L: 9.04%- 17.796 mg/L: 4.18%- 7.780 mg/L: 5.43%- 18.725 mg/L: 5.02%Total CV% (POL sites):- 0.798 mg/L: 8.58%- 4.796 mg/L: 7.37%- 0.758 mg/L: 8.13%- 17.796 mg/L: 4.02%- 7.780 mg/L: 5.24%- 18.752 mg/L: 4.78%
Linearity	(Implicitly to support AMR)	Linearity data and LOQ data support Analytical Measuring Range (AMR) of 0.47 mg/L to 23.0 mg/L.
Limit of Detection (LOD)	(Implicitly to determine lower detection limit)	LOD is 0.15 mg/L
Limit of Quantitation (LOQ)	(Implicitly to determine lower quantitation limit)	LOQ is 0.47 mg/L
Analytical Specificity (Interference)	< 10% deviation from samples without interferents	Common endogenous substance interference: No significant interference up to: Triglyceride 1000 mg/dL, Ascorbic Acid 176 mg/dL, Bilirubin 40 mg/dL, Bilirubin Conjugated 30 mg/dL, Hemoglobin 20 g/dL, Rheumatoid Factor 250 IU/mL. Common exogenous substance interference: No significant interference up to: Oxaloacetate 200 μM, Glutathione 200 μM, Isoniazid 200 μM, L-DOPA 200 μM.
Method Comparison (Internal)	Slope = 0.90~1.10; r2 ≥ 0.95	Whole blood application: Slope = 0.9871 (0.8122-1.0325), Intercept = -0.4004 (-0.2810 to 0.0540), Correlation coefficient = 0.9511. Range of values: 0.47-22.50. Meets criteria.
Method Comparison (External)	Slope = 0.90~1.10; r2 ≥ 0.95	3 POL Site Combined: Slope = 0.9712 (0.9420-1.0056), Intercept = -0.0870 (-0.0463-0.0686), Correlation coefficient = 0.9836. Range of values: 0.47-22.79. Meets criteria. (Individual site results also within range: Site 1: 0.9195, 0.9889; Site 2: 1.0125, 0.9811; Site 3: 1.0073, 0.9858)
Expected Value/Reference Range	< 5.0 mg/L in 95% of the population tested (verified transferability from predicate)	Verified: < 5.0 mg/L in 95% of the population tested (based on 150 healthy individuals).

2. Sample Size Used for the Test Set and Data Provenance:

Precision (Internal): Three whole blood specimens (0.80 mg/L, 3.25 mg/L, and 12.50 mg/L CRP) were tested. Each sample had 40 total data points (4 runs/day over 10 days for each of three analyzers). The study was performed at Diazyme Laboratories, indicating in-house data. The document does not specify the origin of the whole blood specimens (e.g., country). It is a prospective study as tests were performed specifically for device evaluation.
Precision (External): Six whole blood samples across a range of CRP levels were used. At each of three Physician Office Laboratories (POLs), two whole blood samples were tested. Each sample was run 4 times per day for 5 days. This implies data from POL sites, likely within the USA given the company address. It is a prospective study.
Linearity: Eleven levels of linearity materials prepared by diluting whole blood samples. Tested in triplicate. Data provenance likely in-house (Diazyme Laboratories).
Limit of Detection (LOD) & Limit of Quantitation (LOQ): Details on sample types and number for LOD/LOB/LOQ determination are not provided, but the methodology (CLSI EP17-A) implies specific samples designed for this purpose. Data provenance likely in-house.
Analytical Specificity (Interference): Samples with spiked interfering substances were used. No specific numbers are provided for samples tested per interferent. Data provenance likely in-house.
Method Comparison (Internal): Forty EDTA whole blood specimens. Correspondent plasma samples were also tested. Data provenance likely in-house (Diazyme Laboratories). This is a prospective study as samples were explicitly collected and tested for comparison.
Method Comparison (External): One hundred and twenty (120) paired human whole blood-serum samples were collected from individuals. At three POL sites, 40 whole blood samples were tested at each site. The corresponding 120 plasma specimens were tested at Diazyme Laboratories. 116 samples were used after exclusions. Data provenance is multi-site (3 POLs and Diazyme Laboratories), likely within the USA. This is a prospective study.
Expected Value/Reference Range: 150 whole blood samples from apparently healthy individuals (male and female adults ≥ 18 years of age). Data provenance not explicitly stated but implies collection for this study, likely within the USA. This is a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

For this device, which is an in vitro diagnostic (IVD) test measuring a biomarker (CRP), the "ground truth" is typically the quantitative value obtained from a reference method or a predicate device. There is no mention of "experts" (e.g., radiologists) establishing a subjective ground truth based on interpretation.

For Method Comparison studies, the predicate device (Diazyme hsCRP Assay on Hitachi 917 analyzer, K103557) served as the reference method. The "ground truth" for comparison purposes was the measurement obtained from this predicate device. The qualifications of the operators performing these reference measurements (e.g., lab technicians) are not explicitly detailed but are assumed to be standard for clinical laboratory personnel.

4. Adjudication Method for the Test Set:

Not applicable. This is a quantitative diagnostic test for a biomarker, not a device involving subjective interpretation by multiple readers requiring adjudication. The comparison is against an established predicate device.

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:

Not applicable. This device is an in vitro diagnostic assay and does not involve human "readers" interpreting images or clinical cases that could be assisted by AI. It's a standalone quantitative measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies presented are all standalone performance evaluations of the Diazyme hsCRP POC Test Kit. The device provides a quantitative result without human interpretive input beyond sample handling and operational procedures. The precision, linearity, LOD/LOQ, analytical specificity, and method comparison studies evaluate the algorithm's (and instrument's) ability to accurately and precisely measure CRP.

7. The Type of Ground Truth Used:

The ground truth used for the quantitative performance evaluation (method comparison) was the measurements obtained from a predicate device (Diazyme hsCRP Assay on Hitachi 917 analyzer, K103557). For other studies like precision, linearity, and LOD/LOQ, the "ground truth" refers to the expected or target concentrations of CRP in control or spiked samples. For the reference range, it was the distribution of CRP values in apparently healthy individuals.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. As an immunoturbidimetric assay, it relies on chemical reactions and spectrophotometric measurements, not a trainable algorithm in the typical sense of AI/ML. The "calibration curve" for each lot, stored in an RFID card, is established during manufacturing and is a form of calibration rather than algorithm training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable in the context of AI/ML training. The "ground truth" for the device's calibration curve (if interpreted as analogously to a training set) would be established by measuring known concentrations of CRP calibrators according to established laboratory protocols.

Summary

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|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 CourtPoway, CA 92064USA
Name of Contact Person:	Dr. Abhijit DattaDiazyme Laboratories12889 Gregg CourtPoway, CA 92064Phone: 858-455-4762Fax: 858-455-2120abhijit.datta@diazyme.com
Name of the Device:	Diazyme hsCRP POC Test Kit; Diazyme hsCRP POCControl Kit
Manufacturing Address	Diazyme Laboratories12889 Gregg CourtPoway, CA 92064USA
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.

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Intended Use:

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

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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 . (< 0.5%).
Calibrator

1 x preprogrammed lot specific RFID card in each kit

Control Set

l x 1.0 mL Control 1

l x 1.0 mL Control 2

Performance Testing Summaries:

Precision:

(1) Internal precision study performed at Diazyme Laboratories

The precision of the Diazyme hsCRP POC Test Kit was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline with the following modifications: In the study, three whole blood specimens containing 0.80 mg/L, 3.25 mg/L, and 12.50 mg/L CRP were tested in 4 runs per day over 10 days. Testing was performed on three different SMART Analyzers.

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The mean value (Mean), standard deviation, within run imprecision and total imprecision CV mg/L are calculated and summarized in the following tables:

Within Run precision CV%

	Whole blood 10.80 mg/L hs-CRP	Whole blood23.25 mg/L hs-CRP	Whole blood 312.50 mg/L hs-CRP
Total data points	40	40	40
Mean ( mg/L)	0.813	3.186	12.560
SD	0.0782	0.0901	0.2247
CV	9.62%	2.83%	1.79%

Total Precision CV%

	Whole blood 11.00 mg/L hs-CRP	Whole blood23.25 mg/L hs-CRP	Whole blood 312.50 mg/L hs-CRP
Total data points	40	40	40
Mean ( mg/L)	0.813	3.186	12.560
SD ( mg/L)	0.0664	0.0984	0.2667
CV mg/L	8.17%	3.09%	2.12%

(2) External precision study performed at POL sites

The precision was also evaluated at three (3) physician office laboratories (POL) by intended users such as nurses and office assistants. Six (6) whole blood samples containing C Reactive Protein levels ranging from low to high were used for the external precision study. At each site, 2 whole blood samples were tested. Each sample was run 4 times per day for 5 days using three SMART Analyzers.

The results are summarized in the following table:

Within Run

	Site I		Site 2		Site 3
	Whole	Whole	Whole	Whole	Whole	Whole
	blood 1	blood 2	blood 3	blood 4	blood 5	blood 6
No. ofPoints	20	20	20	20	20	20
Mean(mg/L)	0.798	4.796	0.758	17.796	7.780	18.725
SD (mg/L)	0.0372	0.3369	0.0684	0.7447	0.4225	0.9409
CV	4.67%	7.02%	9.04%	4.18%	5.43%	5.02%

Total

	Site 1		Site 2		Site 3
	Wholeblood 1	Wholeblood 2	Wholeblood 3	Wholeblood 4	Wholeblood 5	Wholeblood 6

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No. ofPoints	20	20	20	20	20	20
Mean(mg/L)	0.798	4.796	0.758	17.796	7.780	18.752
SD (mg/L)	0.0684	0.3674	0.0616	0.7153	0.4082	0.8951
CV	8.58%	7.37%	8.13%	4.02%	5.24%	4.78%

Linearity

A set of eleven levels of linearity materials were prepared by diluting a whole blood sample containing 28.0 mg/L of C Reactive Protein (CRP) with a whole blood sample containing 0.47 mg/L CRP according to Clinical and Laboratory Standards Institute EP6-A and were tested with the Diazyme C Reactive Protein POC Test in triplicate on the SMART Analyzer. Linearity data and the LOQ data support Analytical Measuring Range (AMR) of 0.47 mg/L to 23.0 mg/L.

Limit of Detection

The LOB, LOD and LOQ of Diazyme hsCRP Assay were determined according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline.

Results: LOB is 0.055 mg/L LOD is 0.15 mg/L LOQ is 0.47 mg/L

Analytical specificity

Common endogenous substance interference

Protocol: Clinical and Laboratory Standards Institute EP7-A "Interference Testing in Clinical Chemistry": dose-response guidelines.

Acceptance criteria: < 10% deviation from samples without interferents.

The common interfering substances had no significant interference up to the concentrations summarized below. のお気になっています。この日、日本の日本の出会いということです。この日、日本の日本の出来ないので、日本の日本の日本の日本の日本の

Interference	Concentration
Triglyceride	1000 mg/dL
Ascorbic Acid	176 mg/dL
Bilirubin	40 mg/dL
Bilirubin Conjugated	30 mg/dL
Hemoglobin	20 g/dL
Rheumatoid Factor	250 IU/mL

Common exogenous substance interference

Protocol: Clinical and Laboratory Standards Institute EP7-A "Interference Testing in Clinical Chemistry": dose-response guidelines.

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Acceptance criteria: < 10% deviation from samples without interferents.

The common interfering substances had no significant interference up to the concentrations summarized below.

Interference	Concentration
Oxaloacetate	200 μM
Glutathione	200 μM
Isoniazid	200 μM
L-DOPA	200 μM

Method comparison with predicate device:

Protocol: Clinical and Laboratory Standards Institute EP9-A2 - Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline-Second Edition (2002).

Acceptance Criteria: Slope = 0.90~1.10; r2≥ 0.95

(1) Internal method comparison

A total of forty EDTA whole blood specimens were tested with Diazyme hsCRP POC Test on SMART analyzer. The correspondent plasma samples were tested with Diazyme hsCRP Assay on Hitachi 917 analyzer (predicate K103557).

The regression results are summarized in the following table:

n	Whole blood application
Slope(w/ 95% Confidence Interval)	0.9871(0.8122-1.0325)
Intercept(w/ 95% Confidence Interval)	-0.4004(-0.2810 to 0.0540)
Correlation coefficient	0.9511
Range of values	0.47-22.50

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(2) External method comparison

Method comparison was also performed at three (3) POL sites by intended users. One hundred and twenty (120) paired human whole blood-serum samples (a tube of venous whole blood and a tube of serum from the same individual) were tested for comparison.

At each site of the three sites, 40 whole blood samples were tested using SMART analyzers. The corresponding one hundred and twenty (120) plasma specimens were tested on Hitachi 917 with predicate device (K103557) at Diazyme Laboratories. One hundred and sixteen were used after excluding four samples that were out of the assay detection range.

	Site 1	Site 2	Site 3	3POL Site Combined
n	38	39	39	116
Slope(w/ 95% Confi-dence Interval)	0.9195(0.8996 - 0.9927)	1.0125(0.9508 - 1.0484)	1.0073(0.9017 - 1.0369)	0.9712(0.9420 - 1.0056)
Intercept(w/ 95% Confi-dence Interval)	0.0531(-0.0395 - 0.1689)	-0.0839(-0.1744 - 0.1349)	-0.2795(-0.3237 - 0.0040)	-0.0870(-0.0463 - 0.0686)
Correlation co-efficient	0.9889	0.9811	0.9858	0.9836
Range of values	0.60-19.55	0.47-14.00	0.51-22.79	0.47-22.79

The regression results are summarized in the following table:

Expected value/Reference range

Previously established for predicate devices

To verify the transferability of the reference interval from the predicate device, whole blood samples from 150 apparently healthy individuals were tested using the Diazyme hsCRP POC Test according to CLSI C28-A3 guideline. The 150 whole blood samples were from apparently healthy male and female adults ≥ 18 years of age. The expected normal range is verified: < 5.0 mg/L in 95% of the population tested.

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Image /page/7/Picture/0 description: The image shows a partial logo for the U.S. Department of Health and Human Services. The logo includes the department's seal, which features an emblem with an eagle-like bird. The text "HEALTH & HUMAN SERVICES • USA" is partially visible around the seal. To the right of the seal, the word "DEPARTMENT" is printed in bold, uppercase letters.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Diazyme Laboratories c/o Abhijit Datta 12889 Gregg Court Poway, CA 92064

SEP 2 1 2012

Re: K121558

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 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)

Page 1 of

Regulation Number and Section

§ 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).