Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Description

The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF.

AI/ML Overview

The document describes the Tina-Quant IgG Gen.2 device, an immunoturbidimetric assay for the quantitative determination of IgG in human serum, plasma, and cerebrospinal fluid (CSF). The following information is extracted regarding its acceptance criteria and the study that proves it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the performance characteristics presented. The key performance characteristics are:

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Clinical Relevance)	Reported Device Performance (Tina-Quant IgG Gen.2)	Predicate Device Performance (Dade-Behring N Antisera IgG on BN II)
Measuring Range (CSF)	Relevant range for clinical diagnosis of abnormal protein metabolism and infectious agents, comparable to predicate.	2.0 - 200 mg/L; 2-1000 mg/L with rerun	Depends on concentration of proteins in N Protein Standard SL
Expected Values for IgG in CSF	Clinically acceptable range, comparable to predicate.	10-30 mg/L (according to CRM 470 standardization)	Below 34 mg/L (with reference to CRM 470)
Precision (CSF)	Low Coefficients of Variation (CVs) for reliable measurements.	Within-run CV: 5.74% @ 11.7 mg/L human CSF Between-run CV: 6.52% @ 13.21 mg/L human CSF	Note: no separate values are given for CSF precision
Analytical Sensitivity	Low limit of detection for accurate measurement of low IgG levels.	2 mg/L	Established by lower limit of reference curve; depends on concentration of proteins in N Protein Standard SL
Method Comparison (CSF)	Strong correlation and agreement with a legally marketed predicate device (slope close to 1, intercept close to 0, high r-value).	Slope = 1.042, Intercept = -3.903, r = 0.988 (54 samples, 6.17-65.5 mg/L)	N/A (this is the comparison to the predicate)

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

Test Set Sample Size:
- For the Method Comparison study, 54 samples were used for CSF.
- For Precision, various control sera and human CSF samples were used, with specific concentrations mentioned (e.g., 11.7 mg/L human CSF, 13.21 mg/L human CSF for precision studies). The exact number of samples for each precision test is not explicitly stated as a single total, but rather the results for specific concentrations/controls.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the document. The studies described are analytical performance studies comparing the new device to a predicate device and assessing within-device performance characteristics, not studies relying on expert ground truth for interpretation of clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable to the type of analytical performance studies described in the document. No adjudication method is mentioned as there were no subjective interpretations requiring consensus.

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

This information is not applicable to the Tina-Quant IgG Gen.2 device, as it is an in vitro diagnostic assay (a chemical analyzer) and not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

The performance data presented (measuring range, precision, sensitivity, method comparison) reflects the standalone performance of the Tina-Quant IgG Gen.2 assay as an automated in vitro diagnostic test. This device does not incorporate a human-in-the-loop component for its primary function of quantitative IgG determination.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies of the Tina-Quant IgG Gen.2 device is established by:

Traceability/Standardization: To CRM 470, a certified reference material. This provides a universally accepted standard for IgG measurement.
Comparison to a Legally Marketed Predicate Device: The Dade-Behring N Antisera to Human Immunoglobulins IgG on BN II device, which is already established and accepted in the market.

Therefore, the "ground truth" is based on standardized reference materials and the performance of an established, legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The Tina-Quant IgG Gen.2 is a chemical assay, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Theresa M. Ambrose, PhD 9115 Hague Rd. Indianapolis, IN 46250

2 2005 MAR

Re: K050113

Trade/Device Name: Tina-Quant IgG Gen.2 Regulation Number: 21 CFR 866.55 10 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test Regulatory Class: Class II Product Code: DEW Dated: January 14,2005 Received: January 18,2005

Dear Dr. Ambrose:

This letter corrects our substantially equivalent letter of February 8,2005 regarding the Tina-Quant IgG Gen.2 in which the dates for submission and receipt were incorrectly entered as January 4 and January 6,2005 respectively.

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 (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 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

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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: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 Part 801), please contact the Office of Compliance at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert Beckerh.

Robert L. Becker, Jr., M.D., PhP 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):

Device Name: Tina-Ouant ® IgG Gen.2

Indications For Use:

Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.

Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Prescription Use X AND/OR

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maria Chan
Division Sign-Off

office of in Viro Diagnostic Device Evaluation and Salely Page 1 of ____________________________________________________________________________________________________________________________________________________________________

STORE ...

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510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317) 521-3723Contact Person: Theresa M. Ambrose
Device Name	Proprietary name: Tina-Quant® IgG Gen.2Common name: Immunoglobulin G (IgG) TestClassification name: IgG (gamma chain specific) antigen, antiserum, controls
Device Description	The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF.
Intended use	Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.Note: Serum and plasma cleared under K040434.
Indications for Use	Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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510(k) Summary, Continued

The Tina-Quanta IgG Gen.2 test system is substantially equivalent to other Substantial equivalence devices legally marketed in the United States. We claim equivalence to in Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) IgG assay on the BN I1 cleared under K943997. Both products are intended for use in the quantitative determination of IgG in human CSF.

The following table compares the Tina-Quanta IgG Gen.2 test system with Substantial equivalence the predicate device. comparison

Feature	Tina-Quant ® IgG Gen.2	Dade-Behring N Antisera to Human Immunoglobulins IgG on BN II(predicate)
Intended Use	Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical analyzers.	In vitro diagnostic reagents for the quantitative determination of immunoglobulims (IgG, IgA, and IgM) in human serum as well as of IgG in human urine and cerebrospinal fluid (CSF) using the BN systems.
Indication for Use	Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.	Quantitative determination of the immunoglobulins can provide important information on the humoral immune status.
Assay Protocol	Immunoturbidimetric assay	Immunochemical reaction with formation of immune complexes and measurement of scattered light intensity (nephelometric).
Traceability / Standardization	CRM 470	CRM 470

Sample Types	Serum, plasma, CSF	Serum, plasma, urine, CSF
Reagent Stability	Unopened at 2-8°C: up to theexpiration date	Shelf life at 2-8°C : untilexpiration date
	Opened and refrigerated on theanalyzer: 90 days	Opened, capped at 2-8°C: 4weeks
		On-board: 5 days at 8 hourseach or comparable period oftime (maximum 40 hours)
Controls	Sensitive application (CSF):Precinorm PUC (Proteins inUrine/CSF) / Precipath PUC	For IgG in urine or CSF:N/T Protein Control LC(human)
	Standard application (serum,plasma) :Precinorm Protein /Precipath Protein
Calibrator	Sensitive application (CSF):C.f.a.s. (Calibrator for automatedsystems) PUC	N Proteins Standard SL(human)
	Standard application (serum,plasma) : C.f.a.s. Proteins
Instrument	Roche/Hitachi family ofanalyzers	BN Systems
Limitations	Carryover: to avoid carryover asample probe wash isrecommended.	Turbidity and particles in thesample may interfere withdetermination Samplescontaining particles must becentrifuged prior to testing.
	Icterus: no significantinterference up to an I index of60 (60 mg/dL conjugated orunconjugated bilirubin).
	Falsely low results due to antigenexcess may occur above 1400mg/L
Ferformance Characteristics for CSF application
Measuring Range	2 0 - 200 mg/L2-1000 mg/L with rerun(upper limits depend on higheststandard concentration)	Depends on concentration ofproteins in N Protein StandardSL
Expected Values for IgGin CSF	10-30 mg/L (according to CRM470 standardization)	Below 34 mg/L (with referenceto CRM 470_)

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Precision
	Within-run CV	Intra-Assay CV
	0.65% @ 167.8 mg/L control sera	2.1 % @ 13.5 g/L
	1.38% @ 320.7 mg/L control sera
	5.74% @ 11.7 mg/L human CSF	Inter-Assay CV
		2.7 % @ 13.2 g/L
	Between-run CV
	1.27% @ 166.6 mg/L control sera	Note: no separate values aregiven for CSF precision
	2.07% @ 327.7 mg/L control sera
	6.52% @ 13.21 mg/L human CSF
Analytical Sensitivity	2 mg/L	Established by lower limit ofreference curve; depends onconcentration of proteins in NProtein Standard SL
Method Comparison	Tina-Quant ® IgG Gen.2 (x) vs.Dade-Behring IgG on BNII (y)54 samples (6.17-65.5 mg/L)	N/A
	Slope = 1.042Intercept= 1-3.903r= 0.988

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).