The TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated ETA processor.

Device Description

The TG IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the anti-TG IgG ELISA Kit, based on the provided 510k summary:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a set of pre-defined thresholds that the device must meet in a table. Instead, it presents performance characteristics from studies that demonstrate its capabilities. I will infer the implied acceptance criteria from the reported values, particularly in comparison to a commercially available ELISA kit mentioned in the "Relative Sensitivity and Specificity" section.

Performance Characteristic	Implied Acceptance Criteria (Inferred)	Reported Device Performance (anti-TG IgG ELISA Kit)
Relative Sensitivity	High sensitivity to detect positive cases (implied: comparable to

                           | a benchmark kit, with a lower bound within the 95% CI that indicates acceptable detection)                                                                                                                                              | 83.3% (95% CI: 67.2-93.0)                                                                            |

| Relative Specificity | High specificity to correctly identify negative cases (implied: comparable to a benchmark kit, with a lower bound within the 95% CI that indicates acceptable rejection of negatives) | 97.2% (95% CI: 93.5-99.1) |
| Overall Agreement | High overall agreement with a benchmark kit (implied: overall performance nearing 90% or above, with a lower bound within the 95% CI that indicates acceptable consistency) | 94.8% (95% CI: 90.9-97.4) |
| Clinical Specificity (Normals) | High specificity in a normal population. Specific numerical criteria are not specified, but a high percentage is expected to avoid false positives in healthy individuals. | 97.7% (95% CI: 94.3-99.4) |
| Clinical Sensitivity (Grave's Disease) | Moderate to high sensitivity in Grave's Disease patients; while not an explicit threshold, the reported value (38.5%) should be considered clinically acceptable for an aid in diagnosis based on the device's role. | 38.5% (95% CI: 13.9-68.4) |
| Clinical Sensitivity (Hashimoto's Disease) | Moderate to high sensitivity in Hashimoto's Disease patients; similar to Grave's, the reported value (64.3%) should be acceptable for diagnostic aid. | 64.3% (95% CI: 35.1-87.2) |
| Precision (Intra-assay & Inter-assay CV%) | Low Coefficient of Variation (CV%) for both positive and negative samples across different runs and sites. Although no explicit threshold is given, typically CVs below 15-20% are considered acceptable, especially for quantitative assays. | Max Intra-assay CV%: 61.85% (F, NEG, Site 1, Run 1) Max Inter-assay CV%: 98.47% (F, NEG, Site 1) (Values for positive samples generally much lower, e.g., ~10-15%) |
| Correlation (Manual vs. MAGO Plus) | High correlation between manual and automated methods. The Pearson Correlation Coefficient (r) should be close to 1. | 0.988 (Pearson Correlation Coefficient) |

2. Sample Size and Data Provenance:

Relative Sensitivity and Specificity:
- Test Set Sample Size: 227 (Frozen retrospective sera). The table provided specifies N=213 for calculation after excluding equivocal results.
- Data Provenance: Retrospective sera. Country of origin is not specified but is implied to be relevant to the market the device is seeking approval for, likely the US.
Clinical Sensitivity and Specificity:
- Test Set Sample Size: 207 (Frozen retrospective, clinically characterized sera). The table breaks this down into:
  - Normals: 176 (175 used for calculation)
  - Grave's Disease: 12 (13 used for calculation)
  - Hashimoto's Disease: 16 (14 used for calculation)
- Data Provenance: Retrospective sera. Clinically characterized. Country of origin not specified.
Precision:
- Test Set Sample Size: 6 sera (4 positive, 2 negative) tested 10 times in 3 different runs at 2 different sites.
- Data Provenance: Not specified; likely laboratory samples.
Correlation of Manual and MAGO Plus Results:
- Test Set Sample Size: 91 serum samples.
- Data Provenance: Not specified; likely laboratory samples.
MAGO Plus Precision:
- Test Set Sample Size: 6 sera (implied same a precision study data set).
- Data Provenance: Not specified; likely laboratory samples.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used to establish the ground truth or their qualifications for any of the studies.
For the "Relative Sensitivity and Specificity" study, the comparison is made to "a commercially available ELISA KIT." The "ground truth" here is essentially the results of this comparator kit.
For the "Clinical Sensitivity and Specificity" study, the "ground truth" for patient groups (Normals, Grave's Disease, Hashimoto's Disease) is established through "clinically characterized sera." How this clinical characterization was performed (e.g., by a panel of endocrinologists, by a single specialist for each patient, based on a gold standard diagnostic) is not detailed.

4. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method for the test set in the context of expert review.
For the "Relative Sensitivity and Specificity" study, "Equivocal results were excluded from calculations." This acts as a form of exclusion, but not a multi-expert adjudication to reconcile discrepant results.
For "Clinical Sensitivity and Specificity," "Equivocal results were excluded from calculations" as well.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) ELISA kit, not an imaging or interpretation device that would involve multiple human readers. The studies focus on the analytical and clinical performance of the assay itself.

6. Standalone Performance Study:

Yes, standalone performance was done for the algorithm (the ELISA kit). The primary studies (Relative Sensitivity and Specificity, Clinical Sensitivity and Specificity, Precision) all evaluate the performance of the anti-TG IgG ELISA Kit in isolation. The "Correlation of Manual and MAGO Plus Results" and "MAGO Plus Precision" evaluate its performance when integrated with an automated system, but the core analytical performance is still inherent to the kit itself.

7. Type of Ground Truth Used:

For Relative Sensitivity and Specificity: The "ground truth" was established by comparison to a "commercially available ELISA KIT" designed for detecting anti-TG IgG antibodies. This is a comparator device ground truth.
For Clinical Sensitivity and Specificity: The "ground truth" was based on clinical characterization of the patient sera (categorized as Normals, Grave's Disease, Hashimoto's Disease). This can be considered clinical diagnosis/outcomes data ground truth, although the specific diagnostic criteria and methods for this characterization are not elaborated upon.
For Precision, Correlation, and MAGO Plus Precision: The ground truth is the inherent concentration or presence/absence of the analyte in the tested sera, with consistency and correlation being the metrics of interest against established values or the manual method.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" for the ELISA kit. ELISA kits are typically developed and optimized through iterative R&D processes, but the performance studies described here are for validation rather than training a machine learning model. If any optimization involved specific sample sets, it is not detailed as a formal "training set" in this summary.

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

As a formal "training set" is not described, the method for establishing its ground truth is not applicable/not provided in this summary.

Summary

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510k Summary of Safety and Effectiveness 7 1998 DEC

is summary of 510(k) safety and effectiveness information is heing submitted in accordance with the equirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is :

Applicant Information:

Contact Person:	Norman Jenkins
PhoneNumber.	410-995-0450
Fax Number.	410-995-0448

Device Information:

Trade Name:	anti-TG IgG ELISA Kit
Common Name:	Thyroglobulin IgG EIA Test
Classification Name;	Thyroglobulin Serological Reagent

Juivalent Device:

ELIAS TG Kit

Device Description: The TG IgG FI.ISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum.

TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the Intended Use: The & Intended Use: The & TO 1gO Kir Is antibodies against the Thyroglobulin antigen in senum all on in qualitative detection and quantitiation of antiboones against of the manually or in
the diagnosis of thyroid autoimmune disease . The test can be performed either manually or conjunction with the Mago Plus automated EIA processor.

Principle of Procedure:

T G antigen is bound to microwells. Diluted patient sera, Calibrators and controls are placed inthody complexes I G antigen is bound to microwens. Will bind to the antigen forming antigen antibody complexes lebel antibi incubated. Anti-113 IgGranning and washing. Conjugate (horseradish peroxidase-labeled anti-human
Residual sample is eliminated by aspirating and washing. Conjugate consection Resident sample is eliminated by aspirating and was and the spherests as enverted is opported to an igit) is added and will incubated. In the presence of bound enzymently substrate is converted to an end Stostiale is their added and medical in the problementically at 450 mm (reference 600-630

Touce. The adsorbance of this chu produce can over of IgG antibodies to TG present in the sample.

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Performance Characteristics

A. Relative Sensitivity and Specificity

Frozen retrospective sera from two handed twenty-seven parties of this lesting of this testing, the resting, the resting Frozen retrospective sera from lwo lundred we the sults of this testing, the relative a commercially available ELISA KITTOF FO untiloodies: Discussion in Table 2:

TABLE 2

		Is-anti-TG IgG
	POSITIVE	* EQUIVOCAL	NEGATIVE
POSITIVE	30	1	6**
EQUIVOCAL*	3	0	6
NEGATIVE	5	4	172
Relative SensitivityRelative SpecificityOverall Agreement		$30/36 = 83.3%$$172/177 = 97.2%$$202/213 = 94.8%$	95% CI67.2-93.093.5-99.190.9-97.4

Other ELISA

Equivocal results were excluded from calculations

** Five sera were from a normal population.

NOTE : Please be advised that Telative refers to the assay's results to that of as that of as innihances . No indusent can to NOTE: Prease be attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict discase.

B. Clinical Sensitivity and Specificity Using Characterized Sera

. Ontal of 207 frozen retrospective, clinically characterized sera were assayed using the Is-anti-TG Test Kit. The results obtained are shown in Table 3.

Patient Group:	Positive	Equivocal*	Negative	Total
Normals	4		171	176
Grave's Disease	ਨ	2	୦୯	। રે
Hashimoto's Disease	9	2	5	। G
Clinical Specificity:			95% CI
Normals	:::	171175=97.7%	94.3-99.4
Clinical Sensitivity:			95% CI
Grave's Disease	5/13 = 38.5%==============================================================================================================================================================================		13.9-68.4
Hashimoto's Disease	9/14 = 64.3%==============================================================================================================================================================================		35.1-87.2

TABLE 3

Equivocal results were excluded from calculations

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tive sera were assayed ten times

C. Precision of the Is-anti-TC IgC Test Kit, four positive and wo negative scra wereassayd con tines is shown i To decemine the precision of the Is-anti-TG IgO Test Kit, four positive sen worked in each site is shown in
The in thee different runs at two different sites. The interassay

Tables 4 and 5.

ssay and Interassay Precision

	TABLE 4: Site #1- Intra-Assay and Interassay
SERUM	INTRA-ASSAY RUN 1MEANIU/ml	CV%	INTRA-ASSAY RUN 2MEANIU/ml	CV%	INTRA-ASSAY RUN 3MEANIU/ml	CV%	INTERASSAYMEANIU/ml	CV%
A (POS)	204.8	13.49	193.5	11.35	195.1	11.35	197.8	12.01
B (POS)	449.8	9.94	432.8	12.52	475.0	9.35	452.6	10.95
C (POS)	165.0	13.95	148.5	18.51	160.7	14.94	158.1	15.86
D (POS)	86.2	10.07	72.8	11.09	85.9	10.20	81.6	12.72
E (NEG)	9.1	42.20	7.2	39.26	10.5	17.79	9.0	35.59
F (NEG)	1.8	61.85	0.1	316.23	1.5	56.43	1.1	98.47

te #2- Intra-Assay and Interassay Precision i

	TABLE 5: Site #2 Intra Assay
SERUM	INTRA-ASSAY RUN 1MEANIU/ml	CV%	INTRA-ASSAY RUN 2MEANIU/ml	CV%	INTRA-ASSAY RUN 3MEANIU/ml	CV%	INTERASSAYMEANIU/ml	CV%
A (POS)	181.38	6.65	187.53	5.13	172.40	9.38	180.38	7.72
B (POS)	343.06	5.96	339.81	12.06	313.64	11.09	332.17	10.45
C (POS)	126.43	2.48	130.80	0.81	122.80	10.11	126.19	7.98
D (POS)	71.04	5.56	69.59	8.96	62.52	16.11	67.72	11.70
E (NEG)	13.30	16.24	14.53	11.28	8.32	9.36	12.05	26.15
F (NEG)	3.30	49.09	6.60	62.90	1.61	83.20	3.87	87.64

D. Correlation of Manual and MAGO Plus Results

D. Correlation of Manual and MACO Frida 1100 million in the manual use. In capiralence of
The Is-anti-TC IgC Test Kit has been developed for automation were platical A The Is-anti-TC IgG Test Kit his been developed for annount tost 10 onlined. And 10 common
the manual and MAO Plus procedures, the results of Discrums in Shown in Figure 3. Th The Is-Mitt I O Igo Tex receives, the results of 91serum samples described world be responsible in the more in Figure ... The data
the data and regression line of the obtainc scattergram and regression line of the results obtained with the more of 0.988.
Indicate good correlation with a Pearson Correlation Coefficient of 0.988.
Indicate good corre

Image /page/2/Figure/10 description: This image is a scatter plot comparing MAGO Plus IU/ML values to MANUAL IU/ML values. The x-axis represents MANUAL IU/ML values, ranging from 0 to 900, while the y-axis represents MAGO Plus IU/ML values, ranging from 0 to 1200. The data points are clustered around a straight line, indicating a strong positive correlation between the two sets of values. The correlation coefficient, r, is given as 0.988.

Image /page/2/Figure/11 description: This image contains the text 'FIGURE 3 : Correlation of Manual vs MAGO Plus Results'. The text appears to be a figure label or title, indicating that the image is likely a figure from a research paper or report. The figure likely shows the correlation between manual results and MAGO Plus results. The image is cropped and only contains the text.

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E. MAGO Plus Precision

E. MAGO Plus Precision
The precision of the Is-anti-TC IgCTest Kit when performed on the intra-and interassay precision The precision of the Is-anti-TCT IgC Test Kit when performed on the intribution interessay precision
med by assuying six secatent in three different runs. Table 6 shows the i obtained using the MAGO Plus.

TABLE 6: Site #2
SERUM	INTRA-ASSAY RUN 1		INTRA-ASSAY RUN 2		INTRA-ASSAY RUN 3		INTERASSAY
	MEAN IU/ml	CV%	MEAN IU/ml	CV%	MEAN IU/ml	CV%	MEAN IU/ml	CV%
A (POS)	216.96	10.55	268.01	9.07	264.69	10.67	249.89	13.61
B (POS)	538.50	9.58	541.51	11.08	588.90	6.72	556.30	9.81
C (POS)	191.12	7.30	209.07	10.78	207.64	10.06	203.48	10.30
D (POS)	97.10	8.28	113.77	8.64	114.53	11.19	108.47	11.95
E (NEG)	17.40	21.73	10.41	29.34	12.34	40.64	13.38	36.70
F (NEG)	8.82	32.67	6.54	42.03	6.13	52.93	7.16	43.34

TABLE 6 : Site #2- Intra-Assay and Interassay Precision - MAGO Plus

MAGO Plus

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

DEC 1 5 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Norman Jenkins President Columbia Bioscience, Inc. 8775 M Centre Park Drive, #559 Columbia, Maryland 21045

K983553 Re : K983553
Trade Name: Is Anti-TG IgG ELISA Test System Regulatory Class: II Product Code: Jzo Dated: October 8, 1998 Received: October 9, 1998

Dear Mr. Jenkins:

This letter corrects our substantially equivalent letter of This letter corrects our subbedies of the corrected Indications for Use 1997 regarding the Section 510 (k) notification of statement. statement. We have reviewed your book above and we have determined intent to market the device features a our the indications for use
the device is substantially equivalent (for the indicate devices the device is subscantlarly cquiries were ed predicate devices
stated in the enclosure) to legally marketed predicate the ena stated in the encrosure) co regary marker and 28, 1976, the enactment marketed in interstate commerce price of to devices that have been date of the Medical Device Amendates, of the Federal Food,
reclassified in accordance with the provisions market the device reclassified in accordance with the particles on the device, subject to the general controls provisions of the Act. The general controls to the qeneral concrols provirements tor annual controls provisions of che sices, good manufacturing practice, registration, firsting or academing and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such controlor of olabora - Existing major regulations affecting your device of aan be found in the Code of Federal Requlations, Title 21, Parts 800 can be reasubstantially equivalent determination assumes compliance e with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of I

Job 960

K983553 510(k) Number: Not Known

Device Name: & TG IgG ELISA

Indications For Use: The TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed cither manually or in conjunction with the Mago Plus automated ETA processor.

Peter 2. Malin

(Division Sign-Om
Division of Clinical Laboratory Devices
510(k) Number. K983553

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 3 ・・ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 866.5870 Thyroid autoantibody immunological test system.

(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).