The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

Device Description

The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study detailed in the provided document for the Optilite IgA Kit, organized according to your requested information.

It's important to note that this document is a 510(k) summary for a modification to an existing device (Optilite IgA Kit, K103824). Therefore, the study presented here primarily focuses on confirming that the modified device (with a change from sheep to goat antibody) performs comparably to the predicate device (the original cleared kit) and that the performance characteristics detailed in the original submission still hold true. This is not a study to establish initial performance characteristics, but rather to demonstrate equivalence after a modification.

Acceptance Criteria and Device Performance Study for Optilite IgA Kit (K191985)

This study was conducted to demonstrate that the modified Optilite IgA Kit, with a change in the source of the detection antibody from sheep to goat, maintains comparable performance to the predicate device (Optilite IgA Kit, K103824). The acceptance criteria were primarily based on demonstrating no significant change in performance compared to the previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Relative to Predicate Device's Performance Claims)	Reported Device Performance (Modified Kit)	Conclusion
Precision	No change in performance compared to predicate. Data should support existing precision claims in product insert.	Repeatability & Within Lab: Consistent low CV% (1.0-6.3%) across 5 levels. Between Instrument: Low CV% (0.0-2.9%) across 5 levels. Between Lot: Low CV% (0.8-5.2%) across 5 levels.	Meets Criteria: The results do not indicate any change in performance compared to the cleared device (K103824).
Linearity/Assay Reportable Range	No change in performance compared to predicate. Data should support existing linearity claims in product insert.	Linear regression equation: y=1.007x + 0.159 g/L with R value of 0.999.	Meets Criteria: Results are comparable to those presented in the original product insert, indicating no change in performance.
Kit Stability (Accelerated)	Verified stability in accordance with ISO 23640:2015, with maximum allowable difference of ±15% compared to baseline. Should support 18-month stability claim.	All tested parameters (IR, Controls, Samples 1, 2, 3) passed the accelerated stability criteria, achieving or exceeding the required stability days (e.g., sample 1 achieved 561 equivalent days at 4°C, required 395 days).	Meets Criteria: All parameters passed, verifying the stability claim.
Detection Limit (LoD, LoQ, LoB)	No change in performance compared to predicate. Data should support existing claims in product insert.	LoQ validated at 0.02 g/L (within 8% CV acceptance criteria). LoD estimated at 0.007 g/L; LoB estimated at 0.005 g/L. No change observed after antisera change.	Meets Criteria: No change in performance observed, supporting existing LoB, LoD, and LoQ claims.
Method Comparison (vs. Predicate)	Bland Altman Mean Bias close to 0%, 95% Limits of Agreement indicating good concordance. Passing Bablok slope close to 1, intercept close to 0. High Correlation Coefficient. No indication of change in performance vs. predicate.	Bland Altman Mean Bias: 2.38%, 95% Limits of Agreement: -10.6% to 15.37%. Passing Bablok: y=1.012x + 0.011 (Slope 95% CI: 1.001 to 1.027, Intercept 95% CI: -0.006 to 0.044). Correlation coefficient: 0.998.	Meets Criteria: Results do not indicate any change in performance compared to the cleared device (K103824).
Reference Range Transfer	≤2 samples falling outside of the limits of the original reference interval from 20 tested samples.	19 out of 20 samples gave results within the reference interval (0.947 to 4.043 g/L). One sample was at the lower boundary (<0.021 g/L).	Meets Criteria: Only 1 sample fell outside the quantitative range for a healthy individual, indicating successful transferability of the reference interval.

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

Precision (Repeatability & Within Laboratory): 5 different samples, N=80 per level (total 400 replicates).
Precision (Between Instrument): 5 different samples, N=24 per level (total 120 replicates).
Precision (Between Lot): 5 different samples, N=24 per level (total 120 replicates).
Linearity: High pool (8.59 g/L) and low pool (0.10 g/L) for dilution series. Each diluted sample tested in 3 replicates.
Kit Stability (Accelerated): 6 replicates of controls, internal reference, and samples.
Detection Limit (LoQ): 4 samples tested using 2 reagent lots.
Method Comparison: 102 serum samples, 42 plasma samples (total 144 samples). The document does not specify county of origin, but it is implied to be for US market. The study appears to be prospective as it's conducted to support a new submission for a modified device.
Reference Range Transfer: 20 samples from apparently healthy US donors.

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

This type of in-vitro diagnostic device (measuring Immunoglobulin A levels in blood samples) does not typically involve human expert readers or a "ground truth" derived from expert consensus in the same way an imaging AI device would. The "ground truth" for the performance characteristics (precision, linearity, limits, comparison) is derived from:

Reference materials: Traceability to ERM-DA470k/IFCC for calibration.
Established analytical methods: Results from the predicate device serve as the comparative "reference."
Pre-defined specifications: Acceptance criteria for analytical performance established based on regulatory guidelines (e.g., CLSI standards) and the performance of the predicate device.

Therefore, there is no mention of experts establishing ground truth for the test set in the conventional sense of human readers for an AI imaging study.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic analytical performance study. Adjudication by human experts is typically performed in clinical studies involving interpretation of data (e.g., imagery, patient symptoms) where subjective judgment might be involved. Here, the measurements are quantitative and based on instrument readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC study was not done. This is an in-vitro diagnostic device that quantifies an analyte (IgA) in blood samples. MRMC studies are specific to imaging devices and human interpretation. This device does not involve human readers in its direct use or interpretation of results beyond a lab technician operating the instrument and a clinician interpreting the quantitative IgA values.

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

Yes, the analytical performance studies (precision, linearity, detection limits, method comparison) represent the "standalone" performance of the analytical instrument and reagents. The device provides a direct quantitative measurement, so there isn't a human-in-the-loop directly assisting the measurement process itself, only interpreting the final numerical result.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

Quantitative Reference Materials: The calibration is traceable to an international reference material (ERM-DA470k/IFCC).
Comparative Performance to Predicate Device: The performance of the predicate device (Optilite IgA Kit, K103824) serves as the established "truth" against which the modified device is compared to prove substantial equivalence.
Analytical Standards: Established methods and guidelines (e.g., CLSI standards) define how analytical accuracy, precision, and other parameters are measured and what constitutes acceptable performance.
Known Concentrations in Quality Control (QC) Materials: Pooled human sera with known concentrations are used for controls and calibrators, providing a known value against which measurements are assessed.

8. The Sample Size for the Training Set

This document describes a pre-market notification for a modified in-vitro diagnostic device; as such, it does not detail a "training set" in the context of machine learning or AI algorithm development. The "training" for such a system would typically refer to the initial development and optimization of the assay reagents and instrument parameters. The studies presented here are primarily verification and validation studies to demonstrate that the performance of the modified device is equivalent to the predicate. The specifics of the original assay development/optimization (which could be considered analogous to "training") are not provided here, as this is a 510(k) for a modification.

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

Not applicable in the context of this 510(k) for a modified in-vitro diagnostic device. As explained above, there isn't a "training set" in the machine learning sense. The "ground truth" for the development of the original assay would have involved rigorous biochemical and analytical characterization of the antibodies and their reaction with IgA, optimization of assay conditions (e.g., reagent concentrations, incubation times), and calibration against international reference standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2019

The Binding Site Group Ltd. Natasha Verhaak Regulatory Affairs Officer 8 Calthorpe Road Edgbaston, B15 10T Gb UK

Re: K191985

Trade/Device Name: Optilite IgA Kit Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, And E Immunological Test System Regulatory Class: Class II Product Code: CFN, JIT, JJX Dated: July 22, 2019 Received: July 25, 2019

Dear Natasha Verhaak:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Douglas Jeffery, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191985

Device Name Optilite IgA Kit

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response. Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Optilite IgA Kit Special 510(k) Submission Summary

Submitter Details

Natasha Verhaak Regulatory Affairs Officer The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston Birmingham, West Midlands, B15 1QT, UK Telephone: +44 (0)121 456 9500 Email: natasha.verhaak@bindingsite.com or regulatory.submissions@bindingsite.com

Date Prepared: 1st August 2019

A. 510(k) Number:

K191985

B. Purpose for Submission:

Modification to an existing device

C. Measurand:
lgA
D. Type of Test: Quantitative immunoturbidimetry

E. Applicant:

The Binding Site

F. Proprietary and Established Names:

Optilite IgA Kit

G. Regulatory Information:

1. Regulation section:
  21 CFR 866.5510, Immunoglobulins A, G, M, D, and E immunological test system
1. Classification: Class II
1. Product code: CFN - method, nephelometric, immunoglobulins (G, A, M)
1. Panel: Immunology (82)

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H. Intended use:

1. Intended use(s):
  The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of lgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

The intended use is the same as the cleared kit and has not been changed.

1. Indication(s) for use:
  Same as Intended use.
1. Special conditions for use statement(s):
  Prescription use only
1. Special instrument requirements:
  The Binding Site Optilite analyser

I. Device Description:

The Optilite IgA Kit comprises the following reagents:

Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine.

Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.

Reaction Buffer: Containing 0.099% sodium azide as a preservative.

J. Substantial equivalence information:

1. Predicate device name(s) and 510(k) number(s):
  Optilite IgA Kit (K103824)

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2. Comparison with predicate:

Similarities
Item	Modified device	Registered device
Intended Use	Quantitative in vitro measurement ofIgA	Same
Test Method	Turbidimetric	Same
Specimen Type	Serum, lithium heparin, EDTA plasma	Same
Assay type	Quantitative	Same
On-board Stability	30 days	Same
Calibration traceability	DA470k	Same
Measuring Range	1+0 0.02 - 0.7 g/L1+9 0.20 - 7.00 g/L1+39 0.80 - 28.00 g/L1+99 2.00 - 70g/L	Same
Adult ReferenceInterval	0.845 - 4.990 g/L	Same
Instrument	Optilite	Same
Antigen excesscapacity	40 g/L	Same
Calibration method	Pooled human sera	Same
Controls	Pooled human sera	Same
Open vial stability	3 months	Same
Antibody processing	Affinity purification, specificityconfirmed by IEP	Same
Antibody resting buffer	GBS	Same

Differences
Item	Modified device	Registered device
Source of detectionantibody	Goat antibody	Sheep antibody

K. Standards and Guidance documents referenced:

CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline

CLSI EP5-A3 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition

CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents- 1* Edition

CLSI EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures

EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition

L. Test Principle:

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- Precision/Reproducibility: a.

The precision studies were based on CLSI EP5-A3 Evaluation of Precision Performance of Clinical Quantitative Measurement Methods as was agreed in pre-submission meeting Q171503.

The repeatability and within laboratory study was performed over 20 working days, with 2 runs per day and 2 replicates per run. 5 different samples were assessed using 1 reagent lot on 1 analyser.

Repeatability and Within Laboratory Summary
	N	Mean (g/L)	Within run		Between run		Between day		Total
			SD	CV %	SD	CV %	SD	CV %	SD	CV %
Level 1	80	0.425	0.008	1.9	0.017	3.9	0.019	4.5	0.027	6.3
Level 2	80	0.681	0.010	1.5	0.027	4.0	0.021	3.0	0.036	5.2
Level 3	80	1.148	0.017	1.4	0.038	3.3	0.033	2.9	0.053	4.6
Level 4	80	4.041	0.058	1.4	0.085	2.1	0.107	2.6	0.148	3.7
Level 5	80	6.273	0.063	1.0	0.161	2.6	0.074	1.2	0.188	3.0

Repeatability and Within Laboratory Results:

The between instrument precision study was performed over 6 working days, 2 instruments were tested each day with 2 replicates per instrument. 5 different samples were assessed using 1 reagent lot on 3 different analysers.

Between Instrument Results:

	N	Mean(mg/L)	BetweenInstrument
			SD	CV %
Level 1	24	0.439	0.013	2.9
Level 2	24	0.698	0.000	0.0
Level 3	24	1.171	0.000	0.0
Level 4	24	4.085	0.084	2.0
Level 5	24	6.230	0.174	2.8

The between lot precision study was performed over 6 working days, 2 lots were tested each day with 2 replicates per lot. 5 different samples were assessed using 3 reagent lots on 1 analyser.

Between Lot Results:

	N	Mean(mg/L)	Between Lot
			SD	CV %
Level 1	24	0.442	0.023	5.2
Level 2	24	0.704	0.028	4.0
Level 3	24	1.174	0.038	3.2
Level 4	24	4.087	0.033	0.8
Level 5	24	6.416	0.117	1.8

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The above results do not indicate any change in performance compared to the device cleared in K103824. The precision claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.

b. Linearity/assay reportable range:

A linearity study was carried as per the original submission (K103824), where a dilution series was produced from a high pool with a known concentration of 8.59g/L and a low pool concentration of 0.10 g/L. Each diluted sample was tested in 3 replicates and a linear regression analysis was carried out. The linear regression equation was shown to be y=1.007x + 0.159 g/L with an R value of 0.999.

These results are comparable to those currently presented in the product insert and therefore do not indicate any change in performance compared to the device cleared in K103824. The linearity claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

i) Traceability:
The calibration of the assay is traceable to ERM-DA470k/IFCC.

ii) Kit Stability:

Accelerated Stability

Accelerated stability studies were carried out to verify that the stability of the kit is unchanged in accordance with ISO 23640:2015. 6 replicates of controls, internal reference and samples were tested over a period equivalent to 19 months and analysed in line with EP25-A with a maximum allowable difference of ±15% in order to verify the stability claim of 18 months. Reagents were stored at 37ºC to accelerate the study by a factor of 10.

Accelerated Stability Results

Parameter	IR	Control		Sample
		Low	High	1	2	3
Accelerated stabilityachieved (days)	165	57	57	57	57	57
Equivalent at 4ºC (days)	1625	561	561	561	561	561
Stability required at 4ºC(days)	395	395	395	395	395	395
Decision	Pass	Pass	Pass	Pass	Pass	Pass

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Parameter	IR	Control		Sample
		Low	High	1	2	3
Accelerated stabilityachieved (days)	57	57	132	57	57	76
Equivalent at 4ºC (days)	561	561	1300	561	561	748
Stability required at 4ºC(days)	395	395	395	395	395	395
Decision	Pass	Pass	Pass	Pass	Pass	Pass

Batch 455407

Real Time Stability

To further support the results of the accelerated stability testing, a real time stability study is currently being carried out in accordance with EP25-A and as was agreed in pre-submission meeting Q171503.

On Board Stability

On-board stability studies were carried out as per the original submission and showed no difference in the cleared on-board stability claim

d. Detection limit.

The limit of quantitation (LoQ) for this assay is defined as the bottom of the measuring range, 0.02 g/L. The LoQ validation study was based on CLSI EP17-A2 Evaluation of the Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - 2nd Edition in accordance with pre-submission meeting Q171503. Four samples were tested using two reagent lots. The LoQ claim was validated by all the samples reporting within the acceptance criteria of an allowable CV of 8%.

The limit of detection (LoD) represents the lowest measurable analyte level that can be distinguished from zero, this was estimated as 0.007 g/L in the original submission and the limit of blank (LoB) was estimated to be 0.005 g/L. Additional testing was carried out following the antisera change and no change in performance was observed.

The results generated do not indicate any change in performance compared to the device cleared in K180827. The LoB, LoD and LoQ claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.

e. Analytical specificity:

As per original submission (K103824)

f. Assay cut-off:

Not determined

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3. Comparison studies:

a. Method comparison with predicate device:

A comparison study was performed by analysing 102 serum samples, 42 plasma samples using the modified Optilite IgA Kit and the cleared Optilite kit which is already commercially available. The study was carried out in accordance with pre-submission meeting Q171503. Bland Altman and Passing Bablok regression analysis generated the following results:

Bland Altman Mean Bias	95% Limits of Agreement
2.38%	-10.6 % to 15.37%
Passing Bablok	Slope 95% CI	Intercept 95% CI
$y= 1.012x + 0.011$	1.001 to 1.027	-0.006 to 0.044
Correlation coefficient
0.998
Predicate Sample Range (g/L)	Test Samples Range (g/L)
0.032 – 45.050	0.050 – 41.49

The above results do not indicate any change in performance compared to the device cleared in K103824. The comparison claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.

b. Matrix comparison:

Serum and plasma matrices were included in the above method comparison study. As per the original submission (K103824), no difference between matrices were observed.

3. Clinical studies:

a. Clinical Sensitivity: None determined

b. Clinical specificity: None determined

c. Other clinical supportive data (when a. and b. are not applicable): Not applicable

1. Clinical cut-off:
  None determined

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5. Expected values/Reference range:

Following the protocol agreed in Q171503, 20 samples from apparently healthy US donors were tested using the modified assay. The acceptance criteria for the transfer is ≤2 samples falling outside of the limits of the reference interval to be transferred.

Of the 20 samples tested, 19 gave results within the reference interval, ranging from 0.947 to 4.043 g/L. One sample was at the lower boundary of the reference interval (0.02 g/L) with a result of <0.021 g/L. The results of this study therefore meet the acceptance criteria and indicate that the reference interval can be transferred from the originally cleared device.

N. Proposed Labelling:

The labelling is sufficient, and it satisfies the requirements of 21 CFR Part 809.10.

The labelling is the same as the cleared kit and has not been changed.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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).