The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.

Device Description

The Optilite Low Level Albumin Kit is comprised of the following reagents: Antiserum, Calibrator and Controls, and Reaction Buffer. In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Precision	Total precision: %CV < 8.5%	All results met criteria.
	Within-run precision: %CV < 5%	All results met criteria.
	Between-run precision: %CV < 8.5%	All results met criteria.
	Between-day precision: %CV < 8.5%	All results met criteria.
	Between-instrument precision: %CV < 10%	All results met criteria.
Linearity/Reportable Range	%CV for each sample ≤ 8% AND Allowable nonlinearity ±10% or 10% of medical decision point.	Nonlinearity is less than 10% or 10% of the medical decision point in each sample matrix.
Analytical Specificity	Mean results from spiked samples must be within 10% of the mean of control samples.	Data demonstrated the assay was not affected by specified interferents (except Metronidazole at 375mg/L).

Study Details

Sample Sizes Used for Test Set and Data Provenance:
- Precision Study: 5 sample preparations for each matrix (CSF, Urine, Serum) were tested. Each preparation was tested 2 runs per day (each run in duplicate) over 21 days, using 3 analysers. This amounts to 5 samples * 2 runs/day * 2 duplicates/run * 21 days = 420 measurements per sample preparation across all analysers, and 5 samples * 3 analysers = 15 sample preparations across all analysers. The tables specify 'N=84' for each sample number, which likely represents the total number of individual results for a particular sample preparation across the entire study.
- Linearity Study: A dilution series comprising a high pool and low pool for each sample matrix (CSF, Urine, Serum) was tested. Each dilution was tested in 3 replicates. The exact number of samples in the dilution series is not specified.
- Analytical Specificity (Interference) Study: Samples for each sample matrix (CSF, Urine, Serum) were spiked with interfering substances and tested. The number of samples for each matrix is not specified.
- Method Comparison Study:
  - CSF: 166 samples
  - Urine: 191 samples
  - Serum: 142 samples
- Expected Values/Reference Range Verification: 50 adult donor samples for urine and 50 for serum were tested.
- Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. However, the study involved testing of samples, suggesting prospective testing or using banked samples. The applicant is "The Binding Site Ltd." in the UK, so data may originate from there.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is an in vitro diagnostic (IVD) device designed for quantitative measurement of albumin. Ground truth is established by analytical methods and reference standards, not by expert interpretation in the same way as imaging or pathology devices.
- The calibration of the assay is traceable to ERM DA470k/IFCC, which is an international reference material, serving as the "ground truth" for quantitative accuracy.
Adjudication Method for the Test Set:
- Not applicable in the context of this IVD device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of data where consensus among experts is needed to establish ground truth (e.g., classifying medical images). For quantitative measurements, the ground truth is established through metrological traceability to reference standards.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers (e.g., AI for radiology), not for standalone quantitative IVD tests.
Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Yes, the performance characteristics presented (precision, linearity, analytical specificity, detection limit) are for the standalone device/algorithm (Optilite® Low Level Albumin Kit used with the Optilite Analyser). The device provides a quantitative measurement directly. While the indication for use states it should be used in conjunction with other laboratory and clinical findings, the performance data provided is purely instrumental.
Type of Ground Truth Used:
- Reference Standards and Analytical Methods:
  - Calibration is traceable to ERM DA470k/IFCC.
  - Analytical performance studies (precision, linearity, detection limits) rely on well-defined statistical methods (e.g., CLSI EP5-A2, EP6-A, EP17-A) using known concentrations or carefully prepared samples.
  - Method comparison was done against a legally marketed predicate device, indicating its measurements serve as a comparative reference.
Sample Size for the Training Set:
- This is an IVD device and not an AI/machine learning algorithm that requires a separate "training set" in the conventional sense. The development of such assays involves reagent formulation, optimization, and extensive analytical validation. The term "training set" is not applicable here as it would be for AI models.
How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no "training set" in the AI/ML sense. The "ground truth" for developing and validating such an assay comes from established laboratory principles, reference methods, and internationally recognized standards (like ERM DA470k/IFCC).

Summary

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

August 25, 2016

The Binding Site Ltd. Mr. Jon Lauder Regulatory Affairs Officer 8 Calthorpe Road, Edgbaston, Birmingham, West Midlands, B15 1QT UK

Re: K153560

Trade/Device Name: Optilite® Low Level Albumin Kit Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: July 22, 2016 Received: July 26, 2016

Dear Mr. Lauder:

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

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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 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 regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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/ReportaProblem/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 Industry and Consumer Education 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.

Kelly Oli ier -S

For

Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Optilite Low Level Albumin Kit

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)

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Optilite Low Level Albumin Kit

510(k) SUMMARY

A. 510(k) Number:

K153560

B. Purpose for Submission:

New device

C. Measurand:

Albumin

D. Type of Test:

Quantitative immunoturbidimetry

E. Applicant:

The Binding Site

F. Proprietary and Established Names:

Optilite® Low Level Albumin Kit

G. Regulatory Information:

1. Regulation section:
  21 CFR 866.5040, Albumin immunological test system
1. Classification:
  Class II
1. Product code:
  DCF - Albumin antigen, antiserum, control
1. Panel:
  lmmunology (82)

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H. Intended use:

1. Intended use(s):

2. Indication(s) for use:

Same as Intended use.

3. Special conditions for use statement(s):

Prescription use only

1. Special instrument requirements:
  Optilite Analyser (Indiko) (K110035)

l. Device Description:

The Optilite Low Level Albumin Kit is comprised of the following reagents:

Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 1mM ethylenediamine-tetraacetic acid (EDTA) and 0.01% benzamidine..

Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 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.

Note - In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.

J. Substantial equivalence information:

1. Predicate device name(s) and 510(k) number(s):

N Antiserum to Human Albumin K972929 N Protein Standard SL K964062 NT Protein Control SL K964065

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2. Comparison with predicate:

Similarities
Item	Test device	Predicate
Assay type	Quantitative	same
AdultReferenceInterval	Serum: 35000 - 52000mg/LUrine: <30mg/LCSF: <350mg/L	same
SpecimenType	Serum, Urine, CSF	Same (also heparinized andEDTA plasma)
Intended use	The Optilite Low Level Albumin Kit isintended for the quantitative in vitromeasurement of albumin in CSF, urineand serum using the Binding SiteOptilite analyser to aid in the diagnosisof kidney and intestinal diseases. Thistest should be used in conjunction withother laboratory and clinical findings.	In-vitro diagnostic reagent forthe quantitative determinationof albumin in human serum,heparinized and EDTA plasma,as well as in human urine andcerebrospinal fluid (CSF) bymeans of immunonephelometryon the BN Systems.
Calibration	ERM®-DA470k/IFCC	same
Measuringrange (Urine)	11 - 333 (1+0)110 - 3325 (1+9)	2.2 - 68 (1/1)11 - 340 (1/5)44 - 1360 (1/20)220 - 6800 (1/100)440 - 27200 (1/400)
Measuringrange (CSF)	11 - 333 (1+0)110 - 3325 (1+9)	2.2 - 68 (1/1)11 - 340 (1/5)44 - 1360 (1/20)220 - 6800 (1/100)440 - 27200 (1/400)
Measuringrange (Serum)	2200 - 66500 (1+199)	350 - 5500 (1/20)6900 - 110000 (1/100)

Differences
Item	Test device	Predicate
Detectionantibody	Sheep anti-human albumin	Rabbit anti-human albumin
Test method	Turbidimetry	Nephelometry
Open VialStability	3 months	4 weeks at 2-8°C
On-boardstability	30 days	5 days at 8 hours/day for 5mL vials,3 days at 8 hours/day for 2mL vials
Instrument	Binding Site Optilite	Siemens BNII

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K. Standards and Guidance documents referenced:

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

CLSI EP7-A2 Interference Testing in Clinical Chemistry, Approved Guideline - Second Edition

CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach

CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition

CLSI C28-A3: Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory

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):

1. Analytical performance:

a. Precision/Reproducibility:

The studies were based on CLSI EP5-A2, where 5 sample preparations for each matrix were tested in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 3 analysers. Results met the Acceptance criteria for total precision (%CV<8.5%), within-run precision (%CV<5%), between-run precision (%CV<8.5%), between-day precision (%CV<8.5%) and between-instrument precision (%CV<10%). A summary of the results for each sample matrix is shown below; all results are in mg/L.

Sample		1	2	3	4	5
N		84	84	84	84	84
Mean (mg/L)		145.5	281.5	439.9	593.1	975.2
	SD	0.98	3.55	3.72	5.81	13.81
Within Run	%CV	0.7	1.3	0.8	1.0	1.4
	SD	1.44	2.19	6.85	7.08	25.08
Between run	%CV	1.0	0.8	1.6	1.2	2.6
	SD	8.59	14.79	14.18	19.13	74.82
Between day	%CV	5.9	5.3	3.2	3.2	7.7
Between lot	SD	1.67	8.15	5.96	11.15	18.2
	%CV	1.15	2.89	1.36	1.88	1.87
Between instrument	SD	1.13	4.48	10.14	7.75	13.76
	%CV	0.77	1.59	2.3	1.3	1.41
Total	SD	8.77	15.37	16.18	21.21	80.11
	%CV	6.0	5.5	3.7	3.6	8.2

CSF Results:

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Urine Results:

Sample		1	2	3	4	5
	N	84	84	84	84	84
	Mean (mg/L)	22.98	39.04	153.4	275.05	1490.18
Within Run	SD	0.15	0.22	1.54	2.12	13.33
	%CV	0.5	0.6	1.0	0.8	0.9
Between run	SD	0.57	0.68	1.29	3.7	22.3
	%CV	1.9	1.7	0.8	1.3	1.5
Between day	SD	0.67	1.04	2.5	7.78	29.35
	%CV	2.2	2.7	1.6	2.8	2.0
Between lot	SD	0.22	0.1	1.34	3.32	14.02
	%CV	0.97	0.26	0.87	1.21	0.94
Between instrument	SD	0.29	0.19	0.48	3.39	12.53
	%CV	1.24	0.5	0.31	1.23	0.84
Total	SD	0.89	1.26	3.21	8.87	39.2
	%CV	3.0	3.2	2.1	3.2	2.6

Serum Results:

Sample		1*	2*	3	4	5
N		84	84	84	84	84
Mean (mg/L)		4012.8	14007.3	28501.1	36976.7	54447.2
	SD	73.33	179.16	340.92	478.12	866.65
Within Run	%CV	1.8	1.3	1.2	1.3	1.6
	SD	96.21	289.26	261.4	314.41	843.34
Between run	%CV	2.4	2.1	0.9	0.9	1.5
Between day	SD	132.07	526.46	713.95	791.26	1357.89
	%CV	3.3	3.8	2.5	2.1	2.5
	SD	*	*	281.8	235.27	324.17
Between lot	%CV	*	*	0.99	0.64	0.6
Between instrument	SD	102.12	526.57	152.98	195.66	767.86
	%CV	2.54	3.76	0.54	0.53	1.41
Total	SD	179.1	626.84	833.23	976.49	1818.29
	%CV	4.5	4.5	2.9	2.6	3.3

Samples 1 and 2 in the serum study used 4 instruments and one reagent lot. It is therefore not possible to calculate between-lot CV or SD.

b. Linearity/assay reportable range:

The studies followed CLSI EP6-A. whereby linearity was assessed across the curve width at the standard sample dilution (1+0 for CSF and urine and 1+199 for serum). The acceptance criteria were that the %CV for each sample should be ≤8% and the allowable nonlinearity was ±10% or 10% of the medical decision point for each sample matrix.

A dilution series comprising a high pool and low pool for each sample matrix was tested in 3 replicates.

Weighted Linear Regression analysis was performed by plotting the % High Pool against the observed concentration, from which a weighted linear fit was generated for each point in the dilution series. This was then compared with the observed result and the difference calculated. Nonlinearity is less than 10% or 10% of the medical decision point in each sample matrix.

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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:

Real-time stability - Studies to establish shelf-life stability (from the date of manufacture when stored at recommended temperature 2-8°C) were performed on the 510(k)-cleared kit Human Albumin CSF Kit for use on SPAPLUS (K121045) demonstrating stability up to at least 18 months. This kit contains components manufactured using the same raw materials as the test device, with the exception of the high and low control materials, which are manufactured using a different buffer. Additional real time stability was therefore assessed using three manufacturing lots of control materials. Data supports an 18-month stability claim.

Open-vial stability - The Optilite Low Level Albumin Kit Reagent, Calibrator and Controls can be stored, opened at 2-8°C for up to 3 months.

On-board stability - The Optilite Low Level Albumin Kit Reagent can be stored on-board the Optilite Analyser for at least 30 days.

d. Detection limit.

The analytical sensitivity of both kits was determined in accordance with CLSI EP17-A. The Limit of Blank (LoB) was based on 60 determinations of a blank sample and was estimated as the 95% percentile of the distribution. The Limit of Detection (LoD) was calculated according to the equation LoB + 1.645 x SDs where SDs, the standard deviation, was based on 12 determinations of 5 samples with analyte levels near the lower limit of the reportable range. Total error at LoQ was within the maximum allowable total error for each sample matrix.

Urine and CSF: The limit of quantitation (LoQ) for this assay is defined as the bottom of the measuring range, 11mg/L. The LoQ validation study was based on CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation.

Serum: The limit of quantitation (LoQ) for this assay is defined as the bottom of the measuring range, 2200mg/L. The LoQ validation study was based on CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation.

e. Analytical specificity:

Interferences were assessed according to CLSI EP7-A2 by testing samples for each sample matrix. Each sample was spiked with interfering substances and tested. For non-interference to be claimed, the mean results from the spiked samples must be within 10% of the mean of the control samples. The data demonstrated that the assay was not affected by the following substances at the concentrations given below.

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CSF results:

Interferent	Rationale for inclusion	Concentration of interferent
Bilirubin	Endogenous substance.	200mg/L
Haemoglobin	Endogenous substance.	5g/L
Acetaminophen	Common OTC	1324µmol/L
Acetylsalicylic acid	Common OTC	3.63mmol/L

Urine results:

Interferent	Rationale for inclusion	Concentrationof interferent
Ascorbic Acid	Common OTC	200mg/L
Haemoglobin	Endogenous substance.	250mg/L
Acetaminophen	Common OTC	1324µmol/L
Ibuprofen	Common OTC	2425µmol/L
Furosemide	Common drug used to treat oedema and hypertension	90µmol/L
Glybenclamide	Common drug used to treat Type 2 diabetes	3.89µmol/L
Trichloromethiazide	Common drug used to treat oedema and hypertension	50mg/mL
Metformin HCl	Common drug used to treat Type 2 diabetes	8mg/L
Enalapril Maleate	Commonly prescribed ACE inhibitor	496.7ng/mL
Losartan	Common drug used to treat hypertension	2932.08ng/mL
Simvastatin	Common drug used to treat hyperlipidaemia	12.9ng/mL
Acetone	Endogenous substance overproduced by diabetics	7000mg/L
Acetylsalicylic acid	Common OTC	1500mg/L
Calcium chloride	Food additive	780mg/L
Creatinine	Endogenous substance	6000mg/L
Glucose	Endogenous substance	30000mg/L
Magnesium chloride	Food additive	8000mg/L
Sodium citrate	Food additive	1000mg/L
Sodium oxalate	Associated with kidney stones	600mg/L
Urea	Endogenous substance	25g/L
Uric acid	Endogenous substance associated with diabetes	200mg/L
Urobilinogen	Endogenous substance	45mg/L

Metronidazole is known to interfere at a concentration of 375mg/L.

Serum results:

Interferent	Rationale for inclusion	Concentration of interferent
Bilirubin	Endogenous substance.	200mg/L
Haemoglobin	Endogenous substance.	5g/L
Acetaminophen	Common OTC	$1324\mu$ mol/L
Acetylsalicylic acid	Common OTC	3.63mmol/L
Intralipid	Endogenous substance.	2000mg/dL
Triglycerides	Endogenous substance.	1000mg/dL

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f. Assay cut-off:

Not determined

g. Antigen Excess Effects:

Antigen excess was evaluated with serum samples of up to 67384mg/L run at the 1+0 (neat) sample dilution. This is approximately 200 times the top of the calibration curve. Antigen excess was correctly detected and flagged by the analyser in all cases.

2. Comparison studies:

a. Method comparison with predicate device:

Samples were tested in singlicate.

Sample Matrix	Number of samples	Within reference interval	Outside reference interval
CSF	166	110	56
Urine	191	109	82
Serum	142	84	58

Analyte	Passing BablokRegression Equation	Slope(95% CI)	Intercept(95% Cl)	r value (fromlinear regression)
CSF	1.00x + 11.76	0.97 to 1.03	6.16 to 16.83	0.988
Urine	1.06x - 0.44	1.04 to 1.07	-1.28 to 0.31	0.994
Serum	1.01x + 932.82	0.97 to 1.05	-391.08 to 2304.62	0.996

b. Matrix comparison:

None

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:
  These are based on the limits of the reference range for each sample matrix, as follows:

Urine: <30mg/L CSF: <350mg/L. Serum: 35000 - 52000mg/L

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5. Expected values/Reference range:

The urine and serum reference ranges were transferred from the predicate devices and were verified by testing 50 adult donor samples for each matrix. The reference range for albumin in CSF is taken from literature in common with the predicate device.

Urine: <30mg/L CSF: <350mg/L. Serum: 35000 - 52000mg/L

N. Proposed Labelling:

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

O. Conclusion:

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

Regulation Number and Section

§ 866.5040 Albumin immunological test system.

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