K Number

Device Name

Human IgA liquid reagent kit for Use on SPAPlus

Manufacturer

The Binding Site Group Ltd

Date Cleared

2019-09-04

(29 days)

Product Code

CFN

Regulation Number

866.5510

Intended Use

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

Device Description

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents: Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives. Calibrator and Controls: These consist of pooled human serum and are supplied in stabilised liquid form. The concentration of IgA given on the quality control certificate has been obtained by comparison with European Reference Material ERM-DA470k. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K103824

Reference Devices

K103824

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a turbidimetric assay kit and its performance characteristics. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the use of AI/ML. The performance studies focus on analytical metrics like precision, linearity, and method comparison, which are standard for in vitro diagnostic assays.

Therapeutic

No
This device is an in vitro diagnostic (IVD) kit used to measure IgA levels, which aids in diagnosis. It does not treat or directly improve a patient's health condition.

Diagnostic

Yes
Explanation: The device is intended for "quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma" and its "Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," explicitly stating its role in diagnosis.

SaMD (Software as a Medical Device)

The device is a liquid reagent kit, which is a physical component used in a laboratory setting for in vitro diagnostic testing. It is 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 kit is intended for the "quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma". The term "in vitro" is a key indicator of an IVD.
Purpose: The intended use also states that the measurement of IgA "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates a diagnostic purpose.
Sample Type: The device is designed to analyze biological samples (serum, plasma) taken from the human body.
Device Description: The description details reagents used to perform a test on these biological samples.
Regulatory Information: The mention of a "Predicate Device(s)" with a K number (K103824) strongly suggests that this device has gone through a regulatory submission process for IVDs.

All these factors align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

CFN

Device Description

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents:

Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives.

Calibrator and Controls: These consist of pooled human serum and are supplied in stabilised liquid form. The concentration of IgA given on the quality control certificate has been obtained by comparison with European Reference Material ERM-DA470k. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.

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

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)

Precision/Reproducibility:

The precision studies were based on CLSI EP5-A3 Evaluation of Precision Performance of Clinical Quantitative Measurement Methods.
Repeatability and Within Laboratory Study: Performed over 20 working days, with 2 runs per day and 2 replicates per run. 4 different samples were assessed using 1 reagent lot on 1 analyser.
- Level 1: Mean 5.750 g/L, Total CV% 3.4
- Level 2: Mean 3.495 g/L, Total CV% 3.3
- Level 3: Mean 0.346 g/L, Total CV% 7.1
- Level 4: Mean 0.095 g/L, Total CV% 4.1
Between Instrument Precision Study: Performed over 6 working days. 2 instruments were tested each day with 2 replicates per instrument. 4 different samples were assessed using 1 reagent lot on 3 different analysers.
- Level 1: Mean 5.716 mg/L, CV% 0.5
- Level 2: Mean 3.546 mg/L, CV% 1.4
- Level 3: Mean 0.356 mg/L, CV% 0.0
- Level 4: Mean 0.096 mg/L, CV% 1.8
Between Lot Precision Study: Performed over 6 working days. 2 lots were tested each day with 2 replicates per lot. 4 different samples were assessed using 3 reagent lots on 1 analyser.
- Level 1: Mean 5.746 mg/L, CV% 0.0
- Level 2: Mean 3.550 mg/L, CV% 0.0
- Level 3: Mean 0.360 mg/L, CV% 3.2
- Level 4: Mean 0.098 mg/L, CV% 2.7
Key results: The results do not indicate any change in performance compared to the predicate device K103824.

Linearity/Assay Reportable Range:

A linearity study was carried out. A dilution series was produced from a high pool (8.19g/L) and a low pool (0.12 g/L). Each diluted sample was tested in 3 replicates.
Linear regression equation: y=0.993x - 0.230 g/L with an R value of 0.996.
Key results: These results are comparable to those currently presented in the product insert and do not indicate any change in performance compared to K103824.

Traceability, Stability, Expected values:

Traceability: Calibration traceable to ERM-DA470k/IFCC.
Kit Stability: Accelerated stability studies (ISO 23640:2015) were carried out using 6 replicates of controls, internal reference, and samples over a period equivalent to 19 months (37℃ to accelerate by a factor of 10).
- Batch 455406 and 455407 passed stability requirements (57 days accelerated, equivalent to 561 days at 4ºC, required 395 days at 4ºC).
On Board Stability: Studies carried out as per original submission showed no difference in the cleared on-board stability claim.

Detection Limit:

Limit of quantitation (LoQ): 0.02 g/L (bottom of measuring range). Validated based on CLSI EP17-A2 with four samples and two reagent lots, all within acceptance criteria (allowable CV of 8%).
Limit of detection (LoD): Estimated as 0.003 g/L in the original submission.
Limit of blank (LoB): Estimated to be 0.001 g/L.
Key results: No change in performance observed after antisera change compared to K103824.

Assay Cut-off: Not determined.

Method Comparison with Predicate Device:

Study design: 102 serum samples and 42 plasma samples were analyzed using the modified SPAPlus IgA Kit and the cleared SPAPlus kit (K103824).
Bland Altman Mean Bias: -2.18% (95% Limits of Agreement: 0.55% to 3.17%).
Passing Bablok: y= 1.017x + 0.002 (Slope 95% CI: 1.004 to 1.029; Intercept 95% CI: -0.029 to 0.026).
Correlation coefficient: 0.998.
Predicate Sample Range (g/L): 0.038 – 18.26. Test Samples Range (g/L): 0.050 – 18.57.
Key results: The results do not indicate any change in performance compared to K103824.

Matrix Comparison:

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

Clinical Studies:

Clinical Sensitivity: None determined.
Clinical Specificity: None determined.
Other clinical supportive data: Not applicable.

Clinical Cut-off: None determined.

Expected values/Reference Range:

Study design: 20 samples from apparently healthy US donors were tested using the modified assay.
Acceptance criteria: ≤2 samples falling outside the limits of the reference interval to be transferred.
Key results: All 20 samples gave results within the reference interval (1.553 to 4.840 g/L), meeting acceptance criteria.

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

Not Found

Predicate Device(s)

Human IgA liquid reagent kit for use on SPAPLUS® (K103824)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

September 4, 2019

The Binding Site Group Ltd Natasha Verhaak Regulatory Affairs Officer 8 Calthorpe Road Edgbaston Birmingham, B15 1QT Gb

Re: K192116

Trade/Device Name: Human IgA liquid reagent kit for use on SPAPLUS 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 Dated: June 30, 2019 Received: August 6, 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

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

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) K192116

Device Name

Human IgA liquid reagent kit for use on SPAPLUS

Indications for Use (Describe)

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)

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.

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Human IgA Kit for Use on SPAPlus 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: 28th August 2019

A. 510(k) Number:

K192116

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:

Human IgA liquid reagent kit for use on SPAPLUS®

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)

H. Intended use:

1. Intended use(s):

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 SPAPIus analyser

I. Device Description:

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents:

Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives.

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

J. Substantial equivalence information:

1. Predicate device name(s) and 510(k) number(s): Human IgA liquid reagent kit for use on SPAPLUS® (K103824)

2. Comparison with predicate:

Similarities
Item	Modified device	Registered device
Intended Use	Quantitative in vitro measurement of
IgA	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	1/1
0.02 - 0.70 g/L
1/10
0.20 - 7.00 g/L
1/40
0.80 - 28.00 g/L
Where results are greater than the
measuring range samples should be
rerun at 1/10 with a manual offline
dilution of 1/10 to give an overall dilution
of 1/100.	Same
Adult Reference Interval	0.845 - 4.990 g/L	Same
Instrument	SPAPlus	Same
Antigen excess capacity	40 g/L	Same
Calibration method	Calibrator set consisting of pooled
human sera	Same
Controls	low and high, consisting of pooled
human sera	Same
Open vial stability	3 months	Same
Antibody processing	Affinity purification, specificity
confirmed by IEP	Same
Antibody resting buffer	GBS	Same

Differences
Item	Modified device	Registered device
Source of detection antibody	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- 186 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.

M. Performance Characteristics (if/when applicable):

Analytical performance: 1.
- 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. 4 different samples were assessed using 1 reagent lot on 1 analyser.

Repeatability and Within Laboratory Results:

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	5.750	0.109	1.9	0.120	2.1	0.111	1.9	0.196	3.4
Level 2	80	3.495	0.059	1.7	0.095	2.7	0.032	0.9	0.117	3.3
Level 3	80	0.346	0.012	3.4	0.017	4.9	0.013	3.7	0.024	7.1
Level 4	80	0.095	0.003	3.0	0.000	0.0	0.003	2.8	0.004	4.1

The between instrument precision study was performed over 6 working days. 2 instruments were tested each day with 2 replicates per instrument. 4 different samples were assessed using 1 reagent lot on 3 different analysers.

Between Instrument Results:

	N	Mean (mg/L)	Between Instrument
			SD	CV %
Level 1	24	5.716	0.031	0.5
Level 2	24	3.546	0.050	1.4
Level 3	24	0.356	0.000	0.0
Level 4	24	0.096	0.002	1.8

The between lot precision study was performed over 6 working days. 2 lots were tested each day with 2 replicates per lot. 4 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 | 5.746 | 0.000 | 0.0 |
| Level 2 | 24 | 3.550 | 0.000 | 0.0 |
| Level 3 | 24 | 0.360 | 0.012 | 3.2 |
| Level 4 | 24 | 0.098 | 0.003 | 2.7 |

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 out as per the original submission (K103824). A dilution series was produced from a high pool with a known concentration of 8.19g/L and a low pool concentration of 0.12 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=0.993x - 0.230 g/L with an R value of 0.996.

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 37℃ to accelerate the study by a factor of 10.

Accelerated Stability Results

Batch 455406

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

Batch 455407

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

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 0.003 g/L in the original submission and the limit of blank (LoB) was estimated to be 0.001 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 K103824. 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

1. Comparison studies:
- a. Method comparison with predicate device:

A comparison study was performed by analysing 102 serum samples, 42 plasma samples using the modified SPAPlus IgA Kit and the cleared SPAPlus 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
-2.18%	0.55% to 3.17%
Passing Bablok	Slope 95% CI	Intercept 95% CI
$y= 1.017x + 0.002$	1.004 to 1.029	-0.029 to 0.026

Correlation coefficient
0.998
Predicate Sample Range (g/L)	Test Samples Range (g/L)
0.038 – 18.26	0.050 – 18.57

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

4. Clinical cut-off:

None determined

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, all 20 gave results within the reference interval, ranging from 1.553 to 4.840 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.