The Hitachi Clinical Analyzer S TEST reagent cartridge CRP is intended for the quantitative measurement of C-reactive protein in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma. The test system is intended for use in clinical laboratories or physician office laboratories. CRP measurements aid in the evaluation of injury to body tissues, and infection and inflammatory disorders. For in vitro diagnostic use only.

Device Description

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) x 28 mm (D) x 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for CRP. Chemistry reactions: CRP in samples causes an antigen-antibody reaction with latex sensitizes with Goat antihuman C-Reactive Protein antibody to induce agglutination. The concentration of CRP can be determined by measuring this agglutination as the amount of change in absorbance. CRP + Goat anti-human C-reactive protein antibody coated latex -> Agglutination due to antigen-antibody reaction

AI/ML Overview

This document describes the Hitachi Clinical Analyzer S TEST Reagent Cartridge CRP, a device for measuring C-reactive protein.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but rather presents a series of performance studies with their results. I will infer typical acceptance ranges for these metrics based on common laboratory standards and the context of the predicate device.

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance (Hitachi Clinical Analyzer S TEST CRP)	Details
Analytical Sensitivity (Limit of Detection)	≤1 mg/L (Matching predicate)	0.7 mg/L	Meets/Exceeds criteria.
Linearity	1 to 250 mg/L (Matching predicate)	1 to 154 mg/L	The reported linearity of 1 to 154 mg/L is narrower than the predicate's 1 to 250 mg/L. This difference is noted in the comparison table but not further elaborated as a non-conformance. This suggests that the narrower range is acceptable for the intended use or that the upper range of the predicate is not strictly an acceptance criterion for the new device.
Precision (In-house)	Generally <10% CV (Low conc.), <5% CV (Mid/High conc.) per CLSI guidelines	CRP- Low (6.0 mg/L): Total %CV 7.3% CRP- Middle (15.6 mg/dL): Total %CV 7.7% CRP - High (122.1 mg/L): Total %CV 2.8%	Meets criteria. These values are within generally accepted ranges for clinical assays at these concentrations.
Interference	Recoveries between 90% and 110% of neat value	Hemoglobin: no interference up to 1000 mg/dL Unconjugated bilirubin: no interference up to 50 mg/dL Lipemia: no interference up to 2000 mg/dL Ascorbic acid: no interference up to 50 mg/dL	Meets criteria.
Method Comparison (Correlation)	r-value >0.975 for strong correlation, slopes close to 1, intercepts close to 0 (Inferred)	In-house: n=88, r=0.994, Slope=0.99 (0.96-1.01 CI), y-intercept=0.14 (-0.64-0.92 CI) Site 1: n=56, r=0.998, Slope=1.02 (1.00-1.04 CI), Intercept=0.1 (-0.5-0.6 CI) Site 2: n=56, r=0.999, Slope=1.06 (1.05-1.08 CI), Intercept=-0.2 (-0.6-0.2 CI) Site 3: n=55, r=0.998, Slope=1.03 (1.01-1.05 CI), Intercept=0.2 (-0.4-0.8 CI)	Meets criteria. High correlation coefficients (r) close to 1, slopes close to 1, and y-intercepts close to 0 indicate good agreement with the comparative methods.
Matrices Comparison	r-value >0.975 for strong correlation, slopes close to 1, intercepts close to 0 (Inferred)	Lithium Heparin Plasma: r=0.999, Slope=1.00 (0.98-1.01 CI), y-intercept=-0.12 (-0.75-0.52 CI) K3 EDTA Plasma: r=0.999, Slope=0.99 (0.97-1.00 CI), y-intercept=0.06 (-0.55-0.67 CI) Na Citrate Plasma: r=0.999, Slope=1.00 (0.99-1.01 CI), y-intercept=-0.26 (-0.82-0.30 CI)	Meets criteria. High correlation and agreement with serum demonstrate suitability for various plasma types.
Precision (External POL sites)	Similar to in-house precision (Inferred)	Site 1: Low 6.6%, Mid 3.5%, High 5.6% Site 2: Low 14.1%, Mid 2.9%, High 7.1% Site 3: Low 11.2%, Mid 3.9%, High 4.2%	Meets criteria, though Site 2 and Site 3 show slightly higher %CVs for low-level samples compared to Site 1, which is common in POL settings. Overall, these are within acceptable ranges for clinical use, particularly for a POL environment.

Note regarding Acceptance Criteria: The document explicitly lists "no interference" for interference testing with a recovery range of 90-110%. For other metrics, the acceptance criteria are inferred based on the provided data, predicate device performance, and common regulatory expectations for in vitro diagnostic devices.

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

The document describes various studies, and the "test set" here refers to the samples used in these performance evaluations, rather than a specific validation test set for an AI algorithm.
- Analytical Sensitivity (Limits of Detection): Sample size not explicitly stated for this particular study, but the methodology followed CLSI EP17-A.
- Linearity: Sample size not explicitly stated for this particular study, but the methodology followed CLSI EP-6A. Range of linearity 1 to 154 mg/L was found.
- 20-day In-house Precision: Three levels of samples tested over 20 days. Each level was tested in two runs, twice a day. This implies 80 measurements per level (2 runs/day * 2 times/day * 20 days), but the summary tables show mean, SD, %CV for "Total" precision, suggesting consolidated results.
- Interference Testing: Two serum pools with approximately 12 mg/L and 80 mg/L C-reactive protein were used.
- Method Comparison (In-house): 88 clinical specimens.
- Matrices Comparisons: 45 matched serum/plasma samples.
- External Site Precision (Clinical Study): Three blinded serum samples (low, middle, high CRP concentrations) were assayed six times per day for five days at each of three sites, resulting in 30 replicates per level per site.
- Method Comparison (Clinical Study - POL Sites): Approximately 55 serum specimens (56 for Sites 1 & 2, 55 for Site 3).
Data Provenance: The document does not explicitly state the country of origin for the clinical or non-clinical samples. However, the external studies were conducted at "three external POL-type sites," implying a clinical setting within the United States market for which the device is being cleared. The method comparison refers to "clinical specimens." The studies are retrospective in the sense that they use collected samples to establish performance characteristics for the device itself rather than following a patient cohort prospectively.

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

This device is an in vitro diagnostic (IVD) test for quantitative measurement of C-reactive protein. For such devices, "ground truth" is typically established by:

Reference methods (e.g., a "standard laboratory system" or "comparative method" mentioned in the document).
Certified reference materials.
Highly qualified laboratory personnel following standardized protocols.

The document does not mention the use of experts in the traditional sense of medical image interpretation (e.g., radiologists) to establish ground truth for this type of chemical assay. The "ground truth" for the method comparison studies was derived from a "standard laboratory system" or a "comparative method," which would be another FDA-cleared or gold-standard CRP assay administered by qualified laboratory professionals. The qualifications of these professionals are not detailed, but it's understood they would be trained lab technicians/scientists.

4. Adjudication Method for the Test Set:

Not applicable. As this is a quantitative in vitro diagnostic assay, there is no "adjudication method" in the sense of multiple human readers resolving disagreements. Performance is determined by comparing the device's quantitative output against either a reference method's quantitative output or known concentrations in control materials.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 measuring C-reactive protein, not a medical imaging AI device involving human readers. There is no AI component or human-in-the-loop performance described.

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

Not applicable. This device is an automated in vitro diagnostic instrument with reagent cartridges. Its performance is inherently "standalone" in the sense that it performs a chemical analysis and provides a quantitative result without human interpretive input beyond sample loading and result review. There is no separate "algorithm" for distinct standalone performance that would typically be distinguished from a human-in-the-loop scenario. The performance metrics presented (precision, linearity, method comparison) are its standalone performance.

7. The Type of Ground Truth Used:

The ground truth for the device's performance claims was established through:

Reference methods: For method comparison studies, the Hitachi system's results were compared against an "standard laboratory system" (in-house validation) or a "comparative method" (external POL validation). These reference methods serve as the de-facto ground truth for assessing performance.
Known concentrations: For studies like linearity, analytical sensitivity, and precision, samples with known or well-characterized concentrations of CRP (e.g., control materials, spiked samples, reference materials) are used.
Certified protocols: The studies followed established clinical laboratory standards (CLSI guidelines: EP17-A, EP-6A, EP5-A2, EP7-A2, EP9-A2), which dictate how ground truth is appropriately established for these types of assays.

8. The Sample Size for the Training Set:

Not applicable. This device is a diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's operational parameters and performance were likely optimized during its development using various samples, but these are not referred to as a "training set" in this context. The "nonclinical data" and "clinical data" sections describe validation studies, not training.

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

Not applicable (as there is no "training set" in the AI/ML context). As described in point #7, ground truth for the performance evaluation was established using reference laboratory methods, known concentrations, and adherence to CLSI guidelines.

Summary

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K113809

SECTION 8 510(k) SUMMARY

AUG 1 7 2012

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 K113809.

807.92 (a)(1): Name: Address: Hitachi Chemical Diagnostics 630 Clyde Court Mountain View, CA 94043

Phone: FAX: Contact: (650) 961 5501 (650) 969 2745 Mr. Bunichiro Nakajima

807.92 (a)(2): Device name- trade name and common name, and classification

Trade name:

Hitachi Clinical Analyzer S TEST Reagent Cartridge C-Reactive Protein (CRP)

Common Name: Routine chemistry analyzer for C-Reactive Protein (CRP)

Classifications: 21 CFR § 866.5270- C-reactive protein immunological test system (CRP)

807.92 (a)(3): Identification of the legally marketed predicate devices

Reagent Test:

Roche C-Reactive Protein Latex (CRPLX)- K073277

Instrument Platform:

Roche Cobas 8000 Modular Series Analyzer - K100853 Alfa Wasserman Diagnostic Technologies S40 Clinical Analyzer - K091413

807.92 (a)(4): Device Description

Page 1 of 6

Hitachi Chemical Diagnostics, Inc.

Tal: 800 233 8278

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The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) x 28 mm (D) x 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for CRP.

Chemistry reactions:

CRP in samples causes an antigen-antibody reaction with latex sensitizes with Goat antihuman C-Reactive Protein antibody to induce agglutination. The concentration of CRP can be determined by measuring this agglutination as the amount of change in absorbance.

CRP + Goat anti-human C-reactive protein antibody coated latex -> Agglutination due to antigen-antibody reaction

807.92 (a)(5): Intended Use

Page 2 of 6

www.hcdiagnostics.com

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807.92 (a)(6): Technological Similarities and Differences to the Predicate

The following chart describes similarities and differences between the two test systems.

Characteristic	Hitachi S TEST Systems	PREDICATE(S)
Instrument Platform	Hitachi Clinical Analyzer	Roche cobas 8000 - K100853also, Alfa Wasserman S40- K091413
C-Reactive Protein (CRP)	K number- K113809	Roche C-Reactive Protein Latex(CRPLX)K073277
Device Class, Regulation Code	Class II, 21 CFR 866.5270	Same
Classification Product Code	DCN	Same
Intended Use	Quantitative determination of CRP	Same
Testing Environment	Physician office or clinical lab	Clinical lab- Roche cobasPOL/Clin Lab - Alfa Wasserman
Test Principle	Latex agglutination turbidimetricimmunoassay	Particle-enhancedimmunoturbidimetric assay
Specimen Type	Human serum or plasma	Same
Reportable Range	1 to 150 mg/L	1 to 250 mg/L
Detection Wavelength	570/800 nm	-/546 nm
Detection Limit	1 mg/L	Same
Linearity	1 to 154 mg/L	1 to 250 mg/L
Precision	%CVs range from 7.7% (mean 15.6mg/L) to 2.8% (mean 122.1 mg/L)	%CVs range from 0.9% to 2.5%(from product labeling)

807.92 (b)(1): Brief Description of Nonclinical Data

A series of studies were performed that evaluated the following nonclinical performance characteristics for each analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparisons, and matrices comparison between serum and heparin plasma.

Analytical Sensitivity (Limits of Detection)

The study followed CLSI EP17-A, and the sensitivity was found to be 0.7 mg/L.

Linearity

The study followed CLSI EP-6A , and the range of linearity was 1 to 154 mg/L.

Page 3 of 6

Hitachi Chemical Diagnostics, Inc.

630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745

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20-day In-house Precision

The studies followed CLSI EP5-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days. The results were as follows:

Precision Summary:

CRP- Low, Level 1, Summary

CRP	Within-Run	Total
Mean (mg/L)	6.0	6.0
SD (mg/L)	0.34	0.44
% CV	5.7%	7.3%

CRP- Middle, Level 2, Summary

CRP	Within-Run	Total .
Mean (mg/dL)	15.6	15.6
SD (mg/dL)	1.16	1.20
%CV	7.4%	7.7%

CRP - High, Level 3, Summary

CRP	Within-Run	Total
Mean (mg/L)	122.1	122.1
SD (mg/L)	3.01	3.41
% CV	2.5%	2.8%

Interference Testing (per CLSI EP7-A2)

The data demonstrated that the C-reactive protein test system was not affected by high levels of the following substances at the levels noted:

Hemoglobin: no interference up to 1000 mg/dL Unconjugated bilirubin: no interference up to 50 mg/dL Lipemia: no interference up to 2000 mg/dL Ascorbic acid: no interference up to 50 mg/dL

Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the HITACHI Clinical Analyzer by testing two serum pools containing approximately 12 mg/L and 80 mg/L C-reactive protein.

Method Comparison (per CLSI EP9-A2)

A total of 88 clinical specimens, spanning the dynamic range (1 to 125 mg/L), were assayed in singleton and in a blinded fashion by both the Hitachi system and a standard laboratory system. Regression statistics are based on the balance of the paired results, and the data were as follows:

Page 4 of 6

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CRP Regression Statistics:

n	r	Slope(95% CI)	y-intercept(95% CI)	X mean	Y mean
88	0.994	0.99(0.96 to 1.01)	0.14(-0.64 to 0.92)	15 mg/L	15 mg/L

Matrices Comparisons

A study was performed to validate the use of various plasma types, as an alternative to serum, for the Hitachi Clinical Analyzer with S TEST reagent cartridge for C-Reactive Protein. The plasma types were sodium citrate, lithium heparin, and K3 EDTA. Forty-five (45) matched serum/plasma samples that spanned the dynamic range (1 to 123 mg/L) were assayed in singleton and the results were compared using least squares liner regression (plasma = y-axis, each type). The performance characteristics were as follows.

N = 45

Range (serum) = 1 to 123 mg/L

	Lithium HeparinPlasma	K3 EDTA Plasma	Na Citrate Plasma
Slope (95% CIs)	1.00 (0.98 to 1.01)	0.99 (0.97 to 1.00)	1.00 (0.99 to 1.01)
y-intercept (95% CIs)	-0.12 (-0.75 to 0.52)	0.06 (-0.55 to 0.67)	-0.26 (-0.82 to 0.30)
r	0.999	0.999	0.999

807.92 (b)(2): Brief Description of Clinical Data

Studies for precision and method comparison (accuracy) were performed at three external POL-type sites to evaluate the Hitachi Clinical Analyzer with S TEST reagent cartridges for CRP in one of its targeted intended use environments, the physician's office laboratory.

For the external site precision study, each site received three blinded serum samples (the Precision Panel, labeled A, B, and C) that were chosen to represent low, middle, and high concentrations of CRP. Each sample was assayed six times per day for five days, reporting 30 results per level per analyte. Precision estimates for total precision were as follows:

® Hitachi Chemical Diagnostics, Inc.

cdiagnostics.com

630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745

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Site	Sample	Mean	Within-run Precision		Total Precision
			SD (mg/L)	% CV	SD (mg/L)	% CV
Site 1	A	3.9	0.2	5.9%	0.3	6.6%
Site 2	A	3.6	0.4	12.4%	0.5	14.1%
Site 3	A	3.9	0.4	11.6%	0.4	11.2%
Site 1	B	49.7	1.9	3.8%	1.7	3.5%
Site 2	B	52.3	1.5	2.8%	1.5	2.9%
Site 3	B	54.1	1.2	2.3%	2.1	3.9%
Site 1	C	95.5	5.1	5.3%	5.3	5.6%
Site 2	C	92.3	4.0	4.3%	6.5	7.1%
Site 3	C	94.0	3.5	3.7%	4.0	4.2%

CRP (mg/L) n = 30 replicates per sample per site

A series of approximately 55 serum specimens with C-Reactive Protein values ranging from 1 mg/L to 130 mg/L were assayed on the HITACHI Clinical Analyzer at three sites using S TEST CRP (y) and a comparative method as the reference method (x). Linear regression analysis (least squares) yielded the following results:

DATA SUMMARY- C-reactive protein mg/L

Site #	n	Range	Regression Equation	"r"	CI* Slope	CI* Intercept
1	56	1 to 122	y = 1.02x + 0.1	0.998	1.00 to 1.04	-0.5 to 0.6
2	56	1 to 130	y = 1.06x - 0.2	0.999	1.05 to 1.08	-0.6 to 0.2
3	55	1 to 125	y = 1.03x + 0.2	0.998	1.01 to 1.05	-0.4 to 0.8

*95% Confidential Interval

807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing

Nonclinical and clinical testing was performed for the Hitachi Clinical Analyzer with reagent cartridges for CRP. The test system was shown to be safe and effective for its intended use.

Hitachi Chemical Diagnostics, Inc. 830 Clyde Court, Mountain Vlew, CA 94043-2239 Tal· 800 233 6278

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Image /page/6/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures representing health, services, and humanity.

10903 New Hampshire Avenue Silver Spring, MD 20993

Hitachi Chemical Diagnostics, Inc. c/o Ms. Erika B. Ammirati Managing Director 575 Shirlynn Court Los Altos, CA 94022

AUG 1 7 2012

Re: K113809

Trade/Device Name: Hitachi Clinical Analyzer S TEST Reagent Cartridge CRP Regulation Number: 21 CFR §866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: August 10, 2012 Received: August 14, 2012

Dear Ms. Ammirati:

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 class II (Special Controls), 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

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Page 2 - Ms. Ammirati

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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

roge

Reena Philip

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology 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 (if known): K113809

Device Name: Hitachi Clinical Analyzer S TEST Reagent Cartridge CRP

Indications For Use:

Prescription Use × AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnos Device Evaluation a

510K K113869

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).