Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies detail a standard ELISA assay process and analysis of results based on spectrophotometric measurements and comparisons to established thresholds, with no mention of AI or ML algorithms for data interpretation or decision making.

Therapeutic

No.
The device is a diagnostic assay for detecting ANAs and is used as an aid in diagnosing certain autoimmune diseases, not for therapy or treatment.

Diagnostic

Yes.
The "Intended Use / Indications for Use" section explicitly states that the assay "is used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Sjögren's Syndrome, Progressive Systemic Sclerosis, and Polymyositis/Dermatomyositis". This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a laboratory assay kit involving physical components like microtiter wells, reagents (serum, HRP-conjugated anti-human IgG, TMB substrate, Stop Solution), and incubation steps, which are hardware and chemical components, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative assay for the detection of ANAs in human serum." It also states that it is "used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Sjögren's Syndrome, Progressive Systemic Sclerosis, and Polymyositis/Dermatomyositis." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (human serum) to provide information for diagnostic purposes.
Device Description: The description details a laboratory test procedure involving the analysis of serum samples using antigen-coated wells, antibodies, and a substrate to produce a measurable result. This is characteristic of an in vitro diagnostic test.
Performance Studies: The document describes clinical comparison studies, analytical specificity, clinical sensitivity and specificity, precision, reproducibility, and lot-to-lot comparison. These are all standard performance evaluations for in vitro diagnostic devices to demonstrate their accuracy and reliability.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (K040953) indicates that this device is being compared to a previously cleared in vitro diagnostic device.

All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Gold Standard Diagnostics Antibody (ANA) Screen ELISA Test Kit is a qualitative assay for the detection of ANAs in human serum. The assay collectively detects in one well ANAs against double stranded DNA (dsDNA), SSA (Ro60 and Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromeric antibodies along with sera positive for immunofluorescent HEp-2 ANAs.

The assay is used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Sjögren's Syndrome, Progressive Systemic Sclerosis, and Polymyositis/Dermatomyositis, and should be used in conjunction with other laboratory tests and clinical findings.

Product codes (comma separated list FDA assigned to the subject device)

LJM

Device Description

The assay requires a total of 90 minutes incubation time. The test uses antigen coated on microtiter wells. Serum is added to each well and incubated for 30 minutes at room temperature. If antibodies are present they will bind to the antigen in the well. Unbound serum is removed by washing the wells three times. An HRP-conjugated anti-human IgG is then added to each well and incubated for 30 minutes at room temperature. If antibody is present, it will bind to the antibody attached to the antigen on the well. The wells are again washed three times to remove any unbound conjugate. A TMB substrate is added to each well and incubated for 30 minutes at room temperature. If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a Stop Solution and the color intensity is measured spectrophotometrically.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical tests:
- Interfering Substances: Evaluated the effect of potential interfering substances (hemoglobin, bilirubin, rheumatoid factor, triglycerides, heterophile antibody) on samples. Tested substances did not affect performance.
- Prozone (Hook) Effect: Sera with high antibody concentration were tested. The maximum ratio calculated without observing a prozone effect was 12.
Clinical Comparison:
- Correlation study: 848 samples tested at three different sites on both the subject device and a commercially available Anti-Nuclear Antibody ELISA test.
- When equivocal results are treated as positives: Percent positive agreement = 94.9% (C.I. 91.5%% - 97.2%), percent negative agreement = 92.2 % (C.I. 89.7% - 94.2%), overall agreement = 93.0 % (C.I. 91.1% - 95.7%).
- When equivocal results are treated as negatives: Percent positive agreement = 92.3% % (C.I. 88.4%% - 95.2%), percent negative agreement = 96.2 % (C.I. 94.3% - 97.6%), overall agreement = 94.9 % (C.I. 93.2% - 96.3%).
- Analyte comparability: 55 samples (5 known positive for each of 11 analytes) were tested on the proposed ANA Screening test, an FDA-cleared individual analyte test, and an ANA HEp-2 IFA test. Results showed the percentage of samples positive for each analyte.
Analytical Specificity:
- Ten reference ANA sera from CDC and 10 from AMLI were tested in duplicate. All samples gave expected results.
Clinical Sensitivity and Specificity:
- Clinically diagnosed connective tissue disease (CTD) (n=510) and non-CTD (n=201) and other conditions (n=42) sera were evaluated.
- When equivocals considered as Positive: Sensitivity = 83.5% (95% C.I. = 79.1% - 86.0%), Specificity = 96.7% (95% C.I. = 93.6% - 98.6%), Overall = 87.8% (95% C.I. = 85.2% - 90.0%).
- When equivocals considered as Negative: Sensitivity = 79.2% (95% C.I. = 75.4% - 82.7%), Specificity = 96.7% (95% C.I. = 93.6% - 98.6%), Overall = 84.9% (95% C.I. = 82.1% - 87.4%).
Precision:
- Repeatability: Seven samples (3 positive, 1 equivocal, 3 negative) were tested twice a day for ten days. All observed results matched expected results except for one equivocal and one negative sample which matched 90%.
Reproducibility:
- Three samples were tested in duplicate for five days, twice a day, by three technicians per site (total of 3 sites). Mean results are summarized.
- Lot-to-lot comparison: One positive, one equivocal, and one negative sample tested five times each on three different lots. All observed results matched expected.
Expected Values:
- Serum from 99 normal blood donors were tested. Mean unit value, standard deviation, and 95th percentile were calculated (Males: Mean 0.62 U, SD 0.24, 95th percentile 1.09 U; Females: Mean 0.55 U, SD 0.13, 95th percentile 0.82 U).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical Sensitivity and Specificity (compared to predicate device, with equivocals considered as Positive): Sensitivity = 83.5% (95% C.I. = 79.1% - 86.0%), Specificity = 96.7% (95% C.I. = 93.6% - 98.6%).

Clinical Sensitivity and Specificity (compared to predicate device, with equivocals considered as Negative): Sensitivity = 79.2% (95% C.I. = 75.4% - 82.7%), Specificity = 96.7% (95% C.I. = 93.6% - 98.6%).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040953

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).

Summary

0

JAN 28 2014

510(k) Summary

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

Gold Standard Diagnostics 1) Submitter's Name: 2851 Spafford St. Davis, CA. 95618 . Address: 530-759-8000 Phone Number: Contact Person: Napoleon Monce January 28, 2014 Date:
1. Product and Trade Name: Anti-Nuclear Antibody (ANA) Screen ELISA Test

Common Name or Classification Name: Anti-Nuclear Antibody ELISA

Product Code: LJM

1. Legally marketed device to which the submitter claims equivalence: Aesku, Inc. Aeskulisa ANA HEp-2 K040953.

4) Description of the device:

The assay requires a total of 90 minutes incubation time. The test uses antigen coated on microtiter wells. Serum is added to each well and incubated for 30 minutes at room temperature. If antibodies are present they will bind to the antigen in the well. Unbound serum is removed by washing the wells three times. An HRP-conjugated anti-human IgG is then added to each well and incubated for 30 minutes at room temperature. If antibody is present, it will bind to the antibody attached to the antigen on the well. The wells are again washed three times to remove any unbound conjugate. A TMB substrate is added to each well and incubated for 30 minutes at room temperature. If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a Stop Solution and the color intensity is measured spectrophotometrically.

5) Intended use of the device:

The Gold Standard Diagnostics Antibody (ANA) Screen ELISA Test Kit is a qualitative assay for the detection of ANAs in human serum. The assay collectively detects in one well ANAs against double stranded DNA (dsDNA), SSA (Ro60 and Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromeric antibodies along with sera positive for immunofluorescent HEp-2 ANAs.

The assay is used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Systemic Sclerosis. and Syndrome, Progressive Sjögren s Tissue Disease,

1

Polymyositis/Dermatomyositis and should be used in conjunction with other laboratory tests and clinical findings.

6) Comparison with the predicate device:

The Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit was compared The Gold Daniable Diagnootes Pinnstered by Aesku Inc, the Aeskulisa ANA HEp-2 (K040953). Below are tables comparing the two devices.

Item	Device	Predicate
Intended Use	Qualitative assay for the detection of ANAs in human serum.	Same
Assay Format	Qualitative	Same
Technology	ELISA	Same
Calibration	Relative evaluation	Same
Assay Platform	96-well microtiter plates	Same
Controls	Cutoff, Positive and Negative	Same
Conjugate	IgG Conjugate - Anti Human HRP	Same
Substrate	Tetramethylbenzidine (TMB)	Same
Procedure	Sample incubations with micro-well antigen coated plate, followed by a wash step, incubation with an anti-human IgG enzyme conjugate, wash step, incubation with substrate, then addition of a stop solution and reading at 450nm.	Same
Reported Results	OD Ratio	Same
Sample Types	Serum	Same
Sample Dilution	1:101	Same

Differences
Item	Device	Predicate
Antigen Mixture	dsDNA, SSA (Ro60 and Ro52), SSB (La),
Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and
Centromeric antibodies along with sera
positive for immunofluorescent HEp-2 ANAS	dsDNA, histones, SSA (Ro),
SSB (La), Sm, snRNP/Sm,
Scl-70, Jo-1, and Centromeric
antibodies along with sera
positive for
immunofluorescent HEp-2
ANAs
Diluent	Ready to Use	5x concentrate
Wash Solution	10x concentrate	50x concentrate
Stop Solution	1N Sulfuric Acid	1N Hydrochloric Acid
Interpretation	Convert to units. Negative 1.2 units	Convert to Index Value.
Negative 1.0 Index Value

2

6(b1) Nonclinical tests:

Interfering Substances

The effect of potential interfering substances on samples using the Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test was evaluated. Five samples across the reportable range of the assay were spiked with high levels of hemoglobin, bilirubin, rheumatoid factor, and triglycerides. The recommended concentrations from the guideline "Interference Testing In Clinical Chemistry" from the Clinical and Laboratory Standards Institute were used (CLSI EP7-A2). In addition, to assess the interference in the assay from heterophile antibody, two samples at differing unit values were assessed at three concentrations of a Heterophile (HAMA type 1). The tested substances did not affect the performance of the Gold Standard Diagnostics Anti-Nuclear Antibody (ANA) Screen ELISA Test. The results are summarized below:

| Substance | Concentration | Mean Percent
Inhibition |
|-------------------|---------------|----------------------------|
| Hemoglobin | 2 g/L | -2.1% |
| Bilirubin | 20 mg/dL | -3.0% |
| Rheumatoid Factor | 100 IU/mL | 8.8% |
| Triglycerides | 3000 mg/dL | -1.4% |
| Heterophile | 65 µg/mL | 5.4% |
| Heterophile | 32.5 µg/mL | 2.2% |
| Heterophile | 16.25 µg/mL | -0.6% |

Prozone (Hook) Effect

To evaluate the hook effect on the Gold Standard Diagnostics Anti-Nuclear Antibody (ANA) Screen ELISA Test, sera with high antibody concentration were tested. Five samples with high antibody titers were diluted 1:100 to 1:12,000 and the ratio of the sample OD to cutoff OD was calculated. The maximum ratio calculated without observing a prozone effect was 12.

6(b2): Clinical Comparison:

The performance of the Gold Standard Diagnostics Anti-Nuclear Antibody (ANA) Screen ELISA assay was determined by conducting a correlation study tested at three different sites using a total of 848 samples. The samples were tested on both the Gold Standard Anti-Nuclear Antibody (ANA) Screen ELISA assay and a commercially available Anti-Nuclear Antibody ELISA test. The results are summarized in the following table:

	Predicate Device
Overall Results	Positive	Negative	Total
Gold Standard
Diagnostics ANA
Screen ELISA	Positive	251	22	273
	Equivocal	7	23	30
	Negative	14	531	545
	Total	272	576	848

When the equivocal results are treated as positives, the percent positive agreement, percent negative agreement, and the overall agreement along with their 95% confidence intervals are found to be

3

94.9% (C.I. 91.5%% - 97.2%), 92.2 % (C.I. 89.7% - 94.2%), and 93.0 % (C.I. 91.1% - 95.7%), respectively.

When the equivocal results are treated as negatives, the percent positive agreement, percent negative agreement, and the overall agreement along with their 95% confidence intervals are found to be 92.3% % (C.I. 88.4%% - 95.2%), 96.2 % (C.I. 94.3% - 97.6%), and 94.9 % (C.I. 93.2% - 96.3%), respectively.

To demonstrate the test has a performance comparable to that of the individual analyte assays, five samples known to be positive for each analyte (dsDNA, SS-A/Ro 60, SS-A/Ro 52, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, Centromere, and HEp-2 IFA, total of 55 samples) were tested on the proposed ANA Screening test, on an FDA-cleared test that measures each analyte individually, and by ANA HEp-2 IFA test. The percentage of the five samples from each analyte that were positive is shown in the following table:

| Sample
reactivity | GSD test | DNA | SSA
(Ro60) | SSA
(Ro52) | SSB | Sm | Sm/RNP | Scl-70 | Jo-1 | Ribosomal
P | Centromere | Hep-2 |
|----------------------|----------------------|----------------------|---------------|---------------|---------------------|------|--------|--------|------|----------------|------------|-------|
| dsDNA | 100% | 100% | 60% | 20% | 20% | 40% | 40% | 0% | 0% | 20% | 0% | 100% |
| SSA (Ro60) | 100% | 60% | 100% | 40% | 20% | 0% | 0% | 0% | 0% | 20% | 0% | 100% |
| SSA (Ro52) | 80% (1
equivocal) | 20% | 80% | 100% | 20% | 0% | 0% | 0% | 0% | 0% | 0% | 80% |
| SSB | 100% | 20% (1
equivocal) | 100% | 60% | 100% | 0% | 0% | 0% | 0% | 0% | 0% | 100% |
| Sm | 100% | 60% | 0% | 0% | 0% | 100% | 100% | 0% | 0% | 0% | 0% | 100% |
| Sm/RNP | 100% | 80% | 20% | 0% | 0% | 60% | 100% | 0% | 0% | 40% | 0% | 100% |
| SCL-70 | 100% | 20% | 0% | 0% | 0% | 0% | 0% | 100% | 0% | 0% | 0% | 100% |
| Jo-1 | 100% | 0% | 20% | 40% | 0% (1
equivocal) | 0% | 0% | 0% | 100% | 0% | 0% | 20% |
| Ribosomal P | 100% | 80% | 40% | 0% | 0% | 0% | 40% | 0% | 0% | 100% | 0% | 80% |
| Centromere | 100% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 100% | 100% |
| Hep-2 | 100% | 40% | 40% | 0% | 20% | 20% | 40% | 20% | 0% | 40% | 0% | 100% |

Analytical Specificity

Ten reference ANA sera from the Centers for Disease Control (CDC) and 10 sera from the Association of Medical Laboratory Immunologist (AMLI) were tested on the Gold Standard Diagnostics Anti-Nuclear Antibody (ANA) Screen ELISA in duplicate. Below are the observed results for each replicate test. All CDC and AMLI samples gave their expected results.

Sample	Specificity	Result 1	Result 2
CDC #1	DNA	Positive	Positive
CDC #2	SS-A/SS-B	Positive	Positive
CDC #3	RNP, SS-A, SS-B	Positive	Positive
CDC #4	RNP	Positive	Positive
CDC #5	Sm	Positive	Positive
CDC #7	SS-A/Ro	Positive	Positive

4

CDC #8	CENP-B	Positive	Positive
CDC #9	Scl-70	Positive	Positive
CDC #10	Jo-1	Positive	Positive
CDC #12	Ribosomal-P	Positive	Positive
AMLI #1	Negative	Negative	Negative
AMLI #2	SS-A/SS-B	Positive	Positive
AMLI #3	SmRNP	Positive	Positive
AMLI #4	SS-A/Ro	Positive	Positive
AMLI #5	SS-A/SS-B	Positive	Positive
AMLI #6	Scl-70	Positive	Positive
AMLI #7	Jo-1	Positive	Positive
AMLI #8	CENP-B	Positive	Positive
AMLI #9	dsDNA	Positive	Positive
AMLI #10	Negative	Negative	Negative

Clinical Sensitivity and Specificity

Clinically diagnosed connective tissue and non-connective tissue disease sera were evaluated on both the proposed device and on the predicate device. The results are summarized in the following tables:

| Clinical Diagnosis | Number
Tested | Positive
(%) | Equivocal
(%) | Negative
(%) |
|-------------------------------------------|------------------|-----------------|------------------|-----------------|
| Systemic Lupus
Erythematosus (SLE) | 322 | 269 (82.9) | 11 (3.4) | 42 (13) |
| Systemic Sclerosis (SSc) | 40 | 29 (72.5) | 1 (2.5) | 10 (25) |
| Polymyositis (PM) | 12 | 4 (33.3) | 2 (16.7) | 6 (50) |
| Dermatomyositis (DM) | 15 | 4 (26.7) | 2 (13.3) | 9 (60) |
| PM or DM Overlap | 5 | 1 (20) | 1 (20) | 3 (60) |
| Myositis | 10 | 4 (40) | 1 (10) | 5 (50) |
| Mixed Connective Tissue
Disease (MCTD) | 28 | 28 (100) | 0 | 0 |
| Undifferentiated CTD
(UTCD) | 3 | 3 (100) | 0 | 0 |
| Sjögren's Syndrome (SjS) | 75 | 63 (84) | 4 (5.3) | 8 (10.7) |
| Total (CTD) | 510 | 405 (79.4) | 22 (4.3) | 83 (16.3) |

| Clinical Diagnosis | Number
Tested | Positive
(%) | Equivocal
(%) | Negative
(%) |
|------------------------------------|------------------|-----------------|------------------|-----------------|
| Rheumatoid Arthritis (RA) | 100 | 2 (2) | 0 | 98 (98) |
| Osteoarthritis | 20 | 5 (25) | 0 | 15 (75) |
| Primary Biliary Cirrhosis
(PBC) | 8 | 1 (12.5) | 0 | 7 (87.5) |
| Autoimmune Hepatitis
(AIH) | 2 | 0 | 0 | 2 (100) |
| Hashimoto's Thyroiditis | 17 | 0 | 0 | 17 (100) |

5

Grave's Disease	17	0	0	17 (100)
Ulcerative Colitis	5	0	0	5 (100)
Celiac Disease	5	0	0	5 (100)
Primary Anti-phospholipid
Syndrome (PAPS)	22	0	0	22 (100)
Granulomatosis with
polyangitis (Wegener's)	5	0	0	5 (100)
Total (non-CTD)	201	8 (4)	0	193 (96)

| Clinical Diagnosis | Number
Tested | Positive
(%) | Equivocal
(%) | Negative
(%) |
|------------------------------|------------------|-----------------|------------------|-----------------|
| Herpes Simplex Virus (HSV) | 7 | 0 | 0 | 7 (100) |
| Epstein Barr Virus (EBV) | 7 | 0 | 0 | 7 (100) |
| Syphilis | 7 | 0 | 0 | 7 (100) |
| Varicella Zoster Virus (VZV) | 7 | 0 | 0 | 7 (100) |
| Mumps | 7 | 0 | 0 | 7 (100) |
| Rheumatoid Factor | 7 | 0 | 0 | 7 (100) |
| Total (other) | 42 | 0 | 0 | 42 (100) |

The clinical sensitivity and specificity compared to the predicate device is summarized in the following tables:

Overall Results		CTD	Non-CTD & others
		Positive	Negative	Total
Gold Standard
Diagnostics ANA
Screen ELISA	Positive	404	8	412
	Equivocal	22	0	22
	Negative	84	235	319
	Total	510	243	753
Equivocals considered as Positive:		Sensitivity = 83.5% (95% C.I. = 79.1% - 86.0%)
Specificity = 96.7% (95% C.I. = 93.6% - 98.6%)
Overall = 87.8% (95% C.I. = 85.2% - 90.0%)
Equivocals considered as Negative:		Sensitivity = 79.2% (95% C.I. = 75.4% - 82.7%)
Specificity = 96.7% (95% C.I. = 93.6% - 98.6%)
Overall = 84.9% (95% C.I. = 82.1% - 87.4%)

Precision

Assessment of the repeatability of the assay was performed on seven samples; three positive samples, one equivocal sample, and three negative samples. One positive sample was diluted with normal human serum to produce a concentration 20% above the positive ratio cutoff (approximately 1.4 U). One negative sample was diluted to 20% below the negative cutoff ratio (approximately 0.70 units). Each sample was tested twice a day for ten days. All the observed results matched the expected results. The results are summarized in the following table:

6

| Sample | Mean (U) | Range (U) | Expected
qualitative
result | % Observed
matching
expected
result |
|--------|----------|-----------|-----------------------------------|----------------------------------------------|
| 1 | 5.60 | 5.18-5.82 | Positive | 100% |
| 2 | 2.56 | 2.13-2.96 | Positive | 100% |
| 3 | 1.36 | 1.24-1.67 | Positive | 100% |
| 4 | 1.06 | 0.93-1.30 | Equivocal | 90% |
| 5 | 0.73 | 0.62-0.90 | Negative | 90% |
| 6 | 0.34 | 0.27-0.38 | Negative | 100% |
| 7 | 0.16 | 0.12-0.20 | Negative | 100% |

Reproducibility

The reproducibility of the assay was done by testing three samples in duplicate for five days, twice a I he reproducibility of the acchnicians per site. The mean results are summarized in the table below.

| Sample | Mean (U) | Site | Range (U) | Expected
qualitative result | % Observed
result matching
expected result |
|--------|----------|------|-----------|--------------------------------|--------------------------------------------------|
| 1 | 0.20 | 1 | 0.18-0.24 | Negative | 100% |
| 1 | | 2 | 0.18-0.26 | Negative | 100% |
| 1 | | 3 | 0.20-0.27 | Negative | 100% |
| 2 | 1.45 | 1 | 1.05-1.57 | Equivocal | 95% |
| 2 | | 2 | 1.06-1.45 | Equivocal | 95% |
| 2 | | 3 | 1.4-1.55 | Equivocal | 100% |
| 3 | 3.08 | 1 | 2.94-3.14 | Positive | 100% |
| 3 | | 2 | 2.51-3.18 | Positive | 100% |
| 3 | | 3 | 3.04-3.37 | Positive | 100% |

In addition, a lot to lot comparison was performed using three samples, one positive, one equivocal, and one negative sample tested five times each on three different lots. The results are summarized in the table below:

| Sample | Mean (U) | Lot Number | Range (U) | Expected
qualitative result | % Observed
result matching
expected result |
|--------|----------|------------|-----------|--------------------------------|--------------------------------------------------|
| 1 | 1.474 | 1 | 1.42-1.51 | Positive | 100% |
| 1 | | 2 | 1.48-1.60 | Positive | 100% |
| 1 | | 3 | 1.39-1.47 | Positive | 100% |
| 2 | 0.960 | 1 | 0.92-0.96 | Equivocal | 100% |
| 2 | | 2 | 0.92-1.01 | Equivocal | 100% |
| 2 | | 3 | 0.96-1.00 | Equivocal | 100% |

7

3		1	0.51-0.58	Negative	100%
3	0.519	2	0.50-0.52	Negative	100%
3		3	0.50-0.51	Negative	100%

Expected Values

The expected value for a normal patient is a negative result. However, positive ANA results may be found in apparently healthy individuals. In a study, 12.4% of sera from normal healthy donors gave detectable ANA results (1). To evaluate the expected values, serum from 99 normal blood donors were tested. The mean unit value, standard deviation, and the unit value of the 950 percentile are summarized in the following table:

| | Number
Tested | Mean Units | SD | 95th
Percentile |
|------------------------|------------------|------------|------|--------------------|
| Normal Healthy Males | 51 | 0.62 | 0.24 | 1.09 |
| Normal Healthy Females | 48 | 0.55 | 0.13 | 0.82 |

(1) Jaskowski TD. Schroder C. et. al. Screening for Antinuclear Antibodies by Enzyme Immunoassay. Am J Clin Path. 105(4): 468-473. 1996.

8

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 28, 2014

GOLD STANDARD DIAGNOSTICS C/O MR. NAPOLEON MONCE DIRECTOR, PRODUCT DEVELOPEMNT 2851 SPAFFORD ST. DAVIS CA 95618

Re: K131330

Trade/Device Name: Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screen Elisa Test Kit Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: II Product Code: LJM Dated: December 19, 2013

Received: December 23, 2013

Dear Mr. Monce:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

9

Page 2-Mr. Napoleon Monce

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

10

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131330

Device Name

Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit

Indications for Use (Describe)

The Gold Standard Diagnostics Antibody (ANA) Screen ELISA Test Kit is a qualitative assay for the detection of ANAs in human serum. The assay collectively detects in one well ANAs against double stranded DNA (dsDNA), SSA (Ro60 and Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromeric antibodies along with sera positive for immunofluorescent HEp-2 ANAs.

The assay is used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Sjögren's Syndrome, Progressive Systemic Sclerosis, and Polymyositis/Dermatomyositis, and should be used in conjunction with other laboratory tests and clinical findings.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line – continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth A. Stafford -S

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.