Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease.

GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples.

GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis.

For In Vitro Diagnostic Use.

Device Description

Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microalbumin TIA device:

Acceptance Criteria and Device Performance Study

The provided document describes a 510(k) submission for the Good Biotech Corp. Microalbumin TIA system, which includes the TIA reagent, mAlb Calibrator Set 200, and mAlb Control-L, Control-H. The study presented is a comparative performance study to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are inferred from the comparison to predicate devices, focusing on correlation coefficients. The document does not explicitly state pre-defined numerical thresholds as "acceptance criteria" but rather presents the results of the comparison and concludes equivalence.

Acceptance Criterion (Inferred)	Reported Device Performance (GBC Microalbumin TIA)
High correlation with Randox Microalbumin Test kit	Correlation Coefficient: 0.997; Slope: 1.20; Intercept: -0.56 mg/L
High correlation with Wako Micro-Albumin B	Correlation Coefficient: 0.998; Slope: 1.20; Intercept: -2.17 mg/L

Note: The document states "high correlation coefficients" as the basis for substantial equivalence, implying that correlation values close to 1.0 (e.g., above 0.95 or 0.98) would be considered acceptable. The reported values of 0.997 and 0.998 clearly meet this implied criterion. Slopes close to 1.0 and intercepts close to 0 would also indicate good agreement, which are reasonably met here for the purpose of demonstrating equivalence in a 510(k) submission in vitro diagnostic.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: 50 urine samples.
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given that it's a comparative performance study for a diagnostic device, the samples would typically be collected prospectively or from a well-characterized biobank for analytical validation. The company is based in Taiwan, so the samples were likely collected there, but this is not confirmed.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The study is a comparative analytical performance study against existing, legally marketed diagnostic devices (Randox Microalbumin Test kit and Wako Micro-Albumin B). The "ground truth" for each sample is the measurement obtained from these predicate devices. There is no mention of expert consensus or interpretation being used to establish a "ground truth" independent of the and predicate device measurements.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The study compares the quantitative results of the GBC Microalbumin TIA system directly against the results from the predicate devices. There is no need for human adjudication of results in this type of analytical validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for AI-driven image analysis or diagnostic support systems where human readers interpret medical images or data. The GBC Microalbumin TIA system is an in vitro diagnostic (IVD) Turbidimetric Immunoassay (TIA) that provides a quantitative measurement, not an AI system assisting human readers.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the described study essentially represents the "standalone" performance of the GBC Microalbumin TIA system. As an IVD, the device itself performs the measurement (generating a quantitative result) without human input in the interpretation loop, other than standard laboratory practices for sample handling and running the assay. The performance demonstrated (correlation with predicate devices) is of the device on its own.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this analytical validation is established by the measurements obtained from the predicate devices (Randox Microalbumin Test kit and Wako Micro-Albumin B). This is a common approach for demonstrating substantial equivalence for in vitro diagnostics where a new device's analytical performance is compared against established, legally marketed methods.

8. Sample Size for the Training Set

Sample Size for Training Set: This information is not provided in the document. For an IVD like this, there isn't typically a "training set" in the machine learning sense. However, the manufacturer would have performed internal R&D and optimization studies (which might involve various sample sets) to develop and refine the reagent and assay method before the pivotal validation study. The 50 urine samples refer to the validation or test set used for the 510(k) submission.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there's no explicitly defined "training set" with ground truth in the context of this analytical performance study. The development process would have involved establishing the accuracy and precision of the assay, likely using internal reference materials, calibrated standards, and known-concentration samples, but these are part of R&D and not typically detailed as a "training set" in a 510(k) summary for an IVD.

Summary

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APR 2 1. 2005

K050576

510(k) Summary

Safety and Effectiveness

"This summary of 510(k) safety and effectiveness information is being submitted in summary of be of to(s) ==
accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

Microalbumin TIA/ mAlb Calibrator Set 200/ mAlb Control-L, Control-H

Submitter

Good Biotech Corp. Name, 38 34th Rd. Taichung Industrial Park Taichung City 407 Taiwan Address, +886-4-23596873 Telephone number, Victor Chiou Contact person, February 18, 2005 Preparation date

Device

Trade name,	Microalbumin TIA Reagent
	mAlb Calibrator Set 200
	mAlb Control-L, Control-H
Common name,	Urinary albumin immunological diagnostic assay
	Albumin calibrator
	Albumin control
Classification name	Albumin immunological test system (21 CFR § 866.5040)
	Calibrator (21 CFR § 862.1150)
	Quality control material (assayed and unassayed) (21 CFR § 862.1660)
Predicate Device
Trade name,	Randox Microalbumin Test kit
	Wako Micro-Albumin B/ Wako Micro Albumin Calibrator
510(k) number	K002674
	K944664

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Description

Intended Use

Reagent:

Calibrator:

GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples.

Control:

GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis.

For In Vitro Diagnostic Use.

Substantial Equivalence

Comparative performance studies conducted on 50 urine samples yielded high correlation coefficients upon comparison of the GBC Microalbumin TIA system and the predicate devices, Randox Microalbumin Test kit and Wako Micro-Albumin B. The results are summarized below:

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Comparative Method	Slope	Intercept(mg/L)	CorrelationCoefficient	n
Randox	1.20	-0.56	0.997	50
Wako Micro-Albumin B	1.20	-2.17	0.998	50

Conclusion

Good Biotech Corp. Microalbumin TIA system, calibrator set and controls are substantially equivalent to the predicate devices based on their intended purposes, design and the comparison performance results.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

APR 2 1 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor Chiou President Good Biotech Corp. 38, 34th Road Taichung Industrial Park Taichung City Taiwan 407

K050576 Re:

K050570
Trade/Device Name: Microalbumin TIA Reagent; mA1b Calibrator Set 200; mA1b Control- L, Control- H Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DDZ, JIT, JJX Dated: March 3, 2005 Received: March 7, 2005

Dear Mr.Chiou:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) free is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally at the Medical Device Amendments, or to commerce provision to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, mercione, market the act include requirements for annual registration, listing of general controls provisions of the rice, 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 in the lice it may be subject to such additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 Can be found in Thee 21, Courtents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a studenice complies with other requirements of the Act that I DA has made a decommandia an administered by other Federal agencies. You must of ally reactal statutes and regulations and limited to: registration and listing (21

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. 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.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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): K050576

Device Name: Microalbumin TIA Reagent ; mAlb Calibrator Set 200 ; mAlb Control-L, Control-H

Indications For Use:

Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative Oood Blotton of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease.

GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples.

GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis.

For In Vitro Diagnostic Use.

Prescription Use (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 Device Evaluation (ODE)

Carol C Benson
Divison Mgr-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

Page 1 of __ 1 __

K050576

D-1

Regulation Number and Section

§ 866.5040 Albumin immunological test system.

(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.