Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic immunoassay for measuring vitamin D levels. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for performance evaluation. The technology described is CMIA (Chemiluminescent Microparticle Immunoassay).

Therapeutic

No.
This device is an in vitro diagnostic (IVD) assay designed to quantitatively determine 25-hydroxyvitamin D levels, which aids in assessing vitamin D sufficiency. It is not used for treating or diagnosing diseases directly, but rather provides information that can assist healthcare professionals in diagnosis or treatment planning.

Diagnostic

Yes

This device is described as an aid in the assessment of vitamin D sufficiency, which falls under the definition of a diagnostic device used to provide information for medical diagnosis.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic (IVD) assay that uses chemical reagents and hardware (the ARCHITECT iSystem) to measure vitamin D levels in biological samples. It is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of 25-hydroxyvitamin D (25 OH vitamin D) in human serum and plasma." This involves testing biological samples in vitro (outside the body).
Device Description: The description details a "chemiluminescent microparticle immunoassay (CMIA)" using "human serum and plasma." This confirms it's a laboratory test performed on biological specimens.
Performance Studies: The performance studies describe testing on "human serum specimens," "serum panels," "sample pools," and "low-level samples," all of which are biological materials tested in vitro.
Predicate Device: The predicate device listed (K110619) is also an ARCHITECT 25-OH Vitamin D assay, which is a known IVD.

The entire description and the nature of the tests performed clearly indicate that this device is designed for diagnostic testing of biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25 OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.

The ARCHITECT 25-OH Vitamin D Calibrators are for the ARCHITECT iSystem when used for the quantitative determination of 25 hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

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

MRG, JIT, JJX

Device Description

The ARCHITECT 25-OH Vitamin D assay is a quantitative delayed one-step competitive immunoassay to determine the presence of vitamin D in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.

Sample, assay diluent and paramagnetic anti-vitamin D coated microparticles are combined. 25-OH vitamin D present in the sample is displaced from the vitamin D binding protein and binds to anti-vitamin D coated microparticles, forming an antigen-antibody complex.
After incubation, a conjugate containing acridinium-labeled vitamin D is added to the reaction mixture and binds to unoccupied binding sites of the anti-vitamin D coated microparticles.
After further incubation and washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture.
The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a relationship between the amount of 25-OH vitamin D in the sample and the RLUs detected by the ARCHITECT iSystem optics. Results are calculated automatically based on the previously established calibration curve.

Reagents: The ARCHITECT 25-OH Vitamin D reagent kit contains Microparticles (Anti-vitamin D IgG (rabbit monoclonal) coated microparticles in MES Buffer with ProClin 300 preservative), Conjugate (Acridinium-labeled vitamin D in MES Buffer and surfactant with Sodium Azide preservative), and Assay Diluent (Citrate buffer with EDTA, Methanol, 8-anilino-1naphthalenesulfonic acid (ANSA), and surfactant with ProClin 300 preservative).

Calibrators: The ARCHITECT 25-OH Vitamin D calibrators contain 6 Bottles (4.0 mL each) of ARCHITECT 25-OH Vitamin D Calibrators. Calibrators A-F contain PBS buffer and human serum. Calibrators B-F also contain different concentrations of 25-OH vitamin D. Preservatives: ProClin 950, Sodium Azide. The calibrators cover the calibration range of the assay (0.0-160.0 ng/mL, 0.0-400.0 nmol/L). The calibrators are at concentrations from 0.0 ng/mL to 160.0 ng/mL.

Controls: The ARCHITECT 25-OH Vitamin D controls contain 1 Bottle (8.0 mL) Low Control, 1 Bottle (8.0 mL) Medium Control, and 1 Bottle (8.0 mL) High Control. Each contains 25-OH vitamin D prepared in PBS buffer with human serum. Preservatives: ProClin 950, Sodium Azide. The controls are at proposed target 25-OH vitamin D concentrations of 20.0 ng/mL (Low), 40.0 ng/mL (Medium), and 75.0 ng/mL (High). The controls are prepared in PBS (Phosphate Buffered Saline) combined with heat-treated vitamin D depleted human serum.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human serum and plasma (specimen type)

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)

Expected Values (Reference Range)

Study Type: Reference range / expected values determination based on CLSI document C28-A3c.
Sample Size: 283 human serum specimens (129 winter, 154 summer) from apparently healthy individuals.
Data Source: Specimens collected during summer (April to October) and winter (November to March); minimum of 120 specimens for each season. Specimens from male (n = 142) and female (n = 141) subjects 21 years or older from 3 different geographical locations in the 48 contiguous United States (north, south, and central). Included subjects with different skin tones (minimum 30% dark and 30% light) and ethnicities (African American, Hispanic, and Caucasian).
Key Results: The reference range was determined to be from 6.6 ng/mL to 49.9 ng/mL.

20-Day Precision (Within-Laboratory)

Study Type: Precision determination based on NCCLS document EP5-A2.
Sample Size: 3 controls and 7 serum panels.
Standalone Performance:
- Low Control: Mean 20.6 ng/mL, SD 0.68, CV% 3.3
- Medium Control: Mean 40.6 ng/mL, SD 1.23, CV% 3.0
- High Control: Mean 77.3 ng/mL, SD 2.75, CV% 3.6
- Panel A (Mean 5.3 ng/mL): SD 0.37, CV% 6.9
- Panel B (Mean 10.0 ng/mL): SD 0.42, CV% 4.2
- Panel C (Mean 21.1 ng/mL): SD 0.67, CV% 3.2
- Panel D (Mean 30.5 ng/mL): SD 0.94, CV% 3.1
- Panel E (Mean 72.4 ng/mL): SD 2.26, CV% 3.1
- Panel F (Mean 110.6 ng/mL): SD 4.29, CV% 3.9
- Panel G (Mean 153.1 ng/mL): SD 6.93, CV% 4.5
Key Results: The ARCHITECT 25-OH Vitamin D assay demonstrated acceptable precision. Samples at concentrations less than 8.0 ng/mL met the requirement of an SD of ≤ 0.8 ng/mL. Samples at concentrations > 8.0 ng/mL met the requirement of 500 mg/dL.

Interference: Rheumatoid Factor and Heterophilic Antibody

Study Type: Evaluation of potential interference from rheumatoid factor (RF) and heterophilic antibody (GARA) based on CLSI document EP7-A2.
Key Results: The ARCHITECT 25-OH Vitamin D assay is not susceptible to interference effects from RF at ≤ 800 IU/mL or GARA at ≤ 1 ug/mL.

Interference: Other Medical Conditions

Study Type: Evaluation of potential interference from other medical conditions (pregnant females and hemodialysis patients) based on CLSI document EP09-A3, compared to LC-MS/MS.
Sample Size: Pregnant Females (1st Trimester) N=40, (2nd Trimester) N=40, (3rd Trimester) N=40. Hemodialysis Patients N=44.
Key Results: The assay is not susceptible to interference effects from pregnant females (1st, 2nd, and 3rd trimester). The assay demonstrated a mean % bias of -15.3% with hemodialysis patient samples and is therefore susceptible to interference effects from hemodialysis patients.

Method Comparison

Study Type: Method comparison study based on CLSI document EP09-A3.
Sample Size: Minimum of 100 human serum specimens.
Key Results: The Passing-Bablok regression slope was 1.02, the intercept was -0.99, and the correlation coefficient (r-value) was 0.99 for samples across the measuring interval when evaluating the first replicate of the ARCHITECT 25-OH Vitamin D assay to the comparator method (ID-LC-MS/MS). The method comparison data was acceptable.

Tube Type Equivalency

Study Type: Evaluation of suitability of blood collection tube types based on CLSI document EP7-A2.
Sample Size: Samples from a minimum of 40 donors for each tube type.
Key Results: The following blood collection tube types are acceptable for use: serum plastic, serum separator tubes (SST), dipotassium EDTA, tripotassium EDTA, sodium heparin, lithium heparin powder, plasma separator tubes (PST) – lithium heparin gel. All evaluation tube types had lower and upper one-sided 95% CL around the % difference within ± 10% across the measuring interval of the assay when compared to the control tube type (serum plastic).

Specimen Stability

Study Type: Evaluation of serum and plasma specimens stability under various conditions (room temperature storage, 2 to 8°C storage, and freeze/thaw).
Sample Size: 14 serum specimens and 14 plasma specimens.
Key Results: Specimens stored at 2 to 8°C (on or off the clot/cells) for up to 12 days, specimens stored at room temperature (approximately 22 to 30°C) for up to 72 hours, and specimens subjected to 4 freeze thaw cycles after being stored at 2 to 8°C off the clot for up to 12 days are acceptable for use in the ARCHITECT 25-OH Vitamin D assay.

Manual Dilution

Study Type: Demonstration of ability to recover manually-diluted samples.
Sample Size: Minimum of 13 unique donor specimens.
Key Results: The mean (or median) % recovery value was 96.8% for the 1:2 dilution factor, 97.1% for the 1:3 dilution factor, and 103.7% for the 1:4 dilution factor. The ability to recover manually-diluted samples was demonstrated.

Measuring Interval Determination

Study Type: Determination of measuring interval.
Key Results: The measuring interval for the ARCHITECT 25-OH Vitamin D assay has been determined to be 3.4 to 155.9 ng/mL (8.5 to 389.8 nmol/L), based on precision, linearity, limit of quantitation, and bias (method comparison with ID-LC-MS/MS).

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

Not Found

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.

ARCHITECT 25-OH Vitamin D (K110619)

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

§ 862.1825 Vitamin D test system.

(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three intertwined strands, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

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

ABBOTT LABORATORIES JUDITH WALLACH REGULATORY AFFAIRS PROJECT MANAGER DEPT 09AA, BLDG. AP8-1 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064-6038

August 12, 2016

Re: K153375 Trade/Device Name: ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JIT, JJX Dated: July 8, 2016 Received: July 11, 2016

Dear Ms. Judith Wallach:

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 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

1

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 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" (21 CFR 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 yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph. D. Director Division of Chemistry and Toxicology 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) K153375

Device Name ARCHITECT 25-OH Vitamin D 5P02 ARCHITECT 25-OH Vitamin D 5P02 Calibrators ARCHITECT 25-OH Vitamin D 5P02 Controls

Indications for Use (Describe)

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25 OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.

The ARCHITECT 25-OH Vitamin D Calibrators are for the ARCHITECT iSystem when used for the quantitative determination of 25 hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K153375

510(k) Summary (Summary of Safety and Effectiveness)

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

I. Applicant Name

Laura Yelvigi Joglekar, PharmD, ADD, Regulatory Affairs Project Manager Abbott Laboratories Diagnostics Division Dept. 9AA, AP8-1 100 Abbott Park Road Abbott Park, IL 60064-6095 Telephone Number: (224) 667-3503 Fax Number: (224) 667-4836 E-Mail: laura.joglekar@abbott.com Date Summary prepared: August 11, 2016

Grace LeMieux, ADD, Regulatory Affairs Director Telephone Number: (224) 668-0409 Fax Number: (224) 667-4836 E-Mail: grace.lemieux@abbott.com

II. Device Name

ARCHITECT 25-OH Vitamin D 5P02 ARCHITECT 25-OH Vitamin D 5P02 Calibrators ARCHITECT 25-OH Vitamin D 5P02 Controls

Reagents

Trade Name: ARCHITECT 25-OH Vitamin D 5P02 Device Classification: Class II Classification Name: Vitamin D Test System Governing Regulation: 862.1825 Code: MRG

Calibrators

Trade Name: ARCHITECT 25-OH Vitamin D 5P02 Calibrators Device Classification: Class II Classification Name: Calibrator Governing Regulation: 862.1150 Code: JIT

4

Controls

Trade Name: ARCHITECT 25-OH Vitamin D 5P02 Controls Device Classification: Class I, reserved Classification Name: Quality Control Material (assayed and unassayed) Governing Regulation: 862.1660 Code: JJX

III. Predicate Device

Reagents

ARCHITECT 25-OH Vitamin D (K110619)

Calibrators

ARCHITECT 25-OH Vitamin D Calibrators (K110619)

Controls

ARCHITECT 25-OH Vitamin D Controls (K110619)

IV. Description of Device

Reagents

The ARCHITECT 25-OH Vitamin D reagent kit contains:

. Microparticles: (1 bottle x 6.6 mL per 100-test / 1 bottle x 27.0 mL per 500-test / 4 bottles x 27.0 mL per 2000-test) Anti-vitamin D IgG (rabbit monoclonal) coated microparticles in MES Buffer. Minimum concentration: 0.04 % solids. Preservative: ProClin 300.
. Conjugate: (1 bottle x 5.9 mL per 100-test / 1 bottle x 26.3 mL per 500-test / 4 bottles x 26.3 mL per 2000-test). Acridinium-labeled vitamin D in MES Buffer and surfactant. Minimum concentration: 12 ng/mL labeled vitamin D. Preservative: Sodium Azide.
. Assay Diluent: (1 bottle x 10.0 mL per 100-test / 1 bottle x 50.9 mL per 500-test / 4 bottles x 50.9 mL per 2000-test). Citrate buffer with EDTA, Methanol, 8-anilino-1-naphthalenesulfonic acid (ANSA), and surfactant. Preservative: ProClin 300.

5

Calibrators

The ARCHITECT 25-OH Vitamin D calibrators contain:

. 6 Bottles (4.0 mL each) of ARCHITECT 25-OH Vitamin D Calibrators. Calibrators A-F contain PBS buffer and human serum. Calibrators B-F also contain different concentrations of 25-OH vitamin D. Preservatives: ProClin 950, Sodium Azide.
Calibrators cover the calibration range of the assay (0.0-160.0 ng/mL, 0.0-400.0 nmol/L). The calibrators are at the following 25-OH vitamin D concentrations:

| Calibrator | 25-OH Vitamin D
Concentration
(ng/mL) | 25-OH Vitamin D
Concentration
(nmol/L) |
|------------|---------------------------------------------|----------------------------------------------|
| A | 0.0 | 0.0 |
| B | 4.0 | 10.0 |
| C | 10.0 | 25.0 |
| D | 30.0 | 75.0 |
| E | 75.0 | 187.5 |
| F | 160.0 | 400.0 |

Standardization Statement

The ARCHITECT 25-OH Vitamin D assay is standardized against NIST SRM 2972 (National Institute of Standards & Technology Standard Reference Material 2972).

Controls

The ARCHITECT 25-OH Vitamin D controls contain:

. 1 Bottle (8.0 mL) Low Control contains 25-OH vitamin D prepared in PBS buffer with human serum. Preservatives: ProClin 950, Sodium Azide.
. 1 Bottle (8.0 mL) Medium Control contains 25-OH vitamin D prepared in PBS buffer with human serum. Preservatives: ProClin 950, Sodium Azide.
. 1 Bottle (8.0 mL) High Control contains 25-OH vitamin D prepared in PBS buffer with human serum. Preservatives: ProClin 950, Sodium Azide.

The controls are at the following proposed target 25-OH vitamin D concentrations and ranges:

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| | 25-OH Vitamin D
Target Concentration | | 25-OH Vitamin D
Control Range | |
|---------|-----------------------------------------|----------|----------------------------------|-------------|
| Control | (ng/mL) | (nmol/L) | (ng/mL) | (nmol/L) |
| Low | 20.0 | 50.0 | 14.0-26.0 | 35.0-65.0 |
| Medium | 40.0 | 100.0 | 28.0-52.0 | 70.0–130.0 |
| High | 75.0 | 187.5 | 52.5-97.5 | 131.3-243.8 |

The target concentrations for the Low Control and the Medium Control were chosen to bracket the lower and upper medical decision points of 20.0 ng/mL and 30.0 ng/mL, respectively. The target concentration for the High Control was chosen to be near or above the upper end of the expected ranges for 25-OH vitamin D.

The ARCHITECT 25-OH Vitamin D Controls are prepared in PBS (Phosphate Buffered Saline) combined with heat-treated vitamin D depleted human serum (50% for Low Control and 75% for Medium and High Controls).

Principles of the Procedure

The ARCHITECT 25-OH Vitamin D assay is a quantitative delayed one-step competitive immunoassay to determine the presence of vitamin D in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.

1. Sample, assay diluent and paramagnetic anti-vitamin D coated microparticles are combined. 25-OH vitamin D present in the sample is displaced from the vitamin D binding protein and binds to anti-vitamin D coated microparticles, forming an antigen-antibody complex.
1. After incubation, a conjugate containing acridinium-labeled vitamin D is added to the reaction mixture and binds to unoccupied binding sites of the anti-vitamin D coated microparticles.
1. After further incubation and washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture.
1. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a relationship between the amount of 25-OH vitamin D in the sample and the RLUs detected by the ARCHITECT iSystem optics. Results are calculated automatically based on the previously established calibration curve.

V. Indications for Use of the Device

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.

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The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

VI. Comparison of Technological Characteristics

The ARCHITECT 25-OH Vitamin D assay (candidate assay) utilizes a chemiluminescent microparticle immunoassay (CMIA) methodology for the quantitative in vitro determination of 25-OH vitamin D and is intended for use on the ARCHITECT iSystem.

The similarities and differences between the candidate assay and the predicate assay are presented in the following tables.

| | Candidate Device
ARCHITECT 25-OH Vitamin D
(List No. 5P02) | Predicate Device
ARCHITECT 25-OH Vitamin D
(K110619, List No. 3L52) |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Platform | ARCHITECT i2000SR System | Same |
| Methodology | Chemiluminescent Microparticle
Immunoassay (CMIA) | Same |
| Assay Protocol | Delayed 1-step | Same |
| Calibration
Curve Type | 6-point | Same |
| Intended Use
and Indications
for Use | The ARCHITECT 25-OH Vitamin D
assay is a chemiluminescent
microparticle immunoassay (CMIA)
for the quantitative determination of
25-hydroxyvitamin D (25-OH vitamin
D) in human serum and plasma.
The ARCHITECT 25-OH Vitamin D
assay is to be used as an aid in the
assessment of vitamin D sufficiency. | Same |
| Specific Analyte
Detected | 25-OH vitamin D | Same |
| Specimen Type | Serum or plasma | Same |
| | Candidate Device
ARCHITECT 25-OH Vitamin D
(List No. 5P02) | Predicate Device
ARCHITECT 25-OH Vitamin D
(K110619, List No. 3L52) |
| Characteristics | | |
| Tube Types | Serum:
• Serum
• Serum separator tubes (SST)
Plasma:
• Dipotassium EDTA
• Tripotassium EDTA
• Sodium heparin
• Lithium heparin powder
• Plasma separator tubes(PST) – lithium heparin gel | Serum:
• Serum
• SST
Plasma:
• Sodium heparin
• Lithium heparin powder
• PST - lithium heparin gel |
| Components | Microparticles – Anti-vitamin D IgG
(rabbit-monoclonal) coated
microparticles in MES Buffer.
Minimum concentration: 0.04 % solids.
Preservative: ProClin 300.
Conjugate — Acridinium-labeled
vitamin D in MES Buffer and
surfactant. Minimum concentration:
12 ng/mL labeled vitamin D.
Preservative: Sodium Azide.
Assay Diluent - Citrate buffer with
EDTA, Methanol, 8-anilino-1-
naphthalenesulfonic acid (ANSA), and
surfactant. Preservative: ProClin 300. | Microparticles – Anti-human
vitamin D IgG (sheep, polyclonal)
coated microparticles in TRIS
buffer. Minimum concentration:
0.05% solids. Preservatives:
ProClin 300, ProClin 950.
Conjugate — biotinylated vitamin D
anti-biotin IgG (mouse,
monoclonal) acridinium-labeled
conjugate complex in BIS-TRIS
HCl buffer with protein stabilizers
(bovine gamma globulin) and
detergent. Minimum concentration:
1.2 µg/mL anti-biotin IgG and
0.1 µg/mL
vitamin-D-biotin. Preservative:
sodium azide.
Assay Diluent – Assay Diluent
containing acetic acid buffer with
EDTA. Preservatives: ProClin 300,
ProClin 950.
Pre-Treatment 1 - Pre-Treatment 1
containing triethanolamine
methanol buffer and
8-anilino-1-naphtalensulfonic acid
(ANSA).
Pre-Treatment 2 – Pre-Treatment 2
containing triethanolamine
methanol buffer and
8-anilino-1-naphtalensulfonic acid
(ANSA). |

Reagent: Similarities

8

Reagent: Differences

9

| Characteristics | Candidate Device
ARCHITECT 25-OH Vitamin D
(List No. 5P02) | Predicate Device
ARCHITECT 25-OH Vitamin D
(K110619, List No. 3L52) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| On-Board
Storage | Maximum of 21 days | Maximum of 14 days | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Expected Values | 25-OH Vitamin D Values (ng/mL) Central 95% of Dataa Season n Mean Lower Limit Upper Limit Winter 129 16.8 6.2 45.5 Summer 154 19.3 7.0 53.2 Combined 283 18.2 6.6 49.9 a The central 95% of data represents the mean concentration $\pm$ 1.96 $\times$ SD. Representative data; results in individual laboratories and in different geographical areas may vary from these data. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | n=137 Concentration (ng/mL) Median 24.6 2.5th Percentile 60 years old), TSH (0.35 to 4.94 uIU/mL), or intact PTH (15.0 to 68.3 pg/mL) were excluded from this study. The study included specimens from male (n = 142) and female (n = 141) subjects 21 years or older from 3 different geographical locations in the 48 contiguous United States (north, south, and central).

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Specimens from subjects with different skin tones (minimum 30% dark and 30% light) and ethnicities (African American, Hispanic, and Caucasian) were included. No more than 50% of the subjects were taking vitamin D supplement(s).

Two lots of reagents and 1 lot each of calibrators and controls were used to test one replicate of each specimen that met the inclusion criteria. Testing was performed on 2 ARCHITECT i2000SR instruments. Approximately the same number of randomized specimens was tested with each reagent lot/instrument combination.

The reference range was determined to be from 6.6 ng/mL to 49.9 ng/mL. The results are summarized in the following table.

		25-OH Vitamin D Values (ng/mL)
		Central 95% of Data a
Season	N	Mean	Lower Limit	Upper Limit
Winter	129	16.8	6.2	45.5
Summer	154	19.3	7.0	53.2
Combined	283	18.2	6.6	49.9

a The central 95% of data represents the mean concentration ± 1.96 × SD. Representative data; results in individual laboratories and in different geographical areas may vary from these data.

20-Day Precision (Within-Laboratory)

Precision was determined based on guidance from the National Committee for Clinical Laboratory Standards (NCCLS) document EP5-A2. Samples included 3 controls and 7 serum panels.

Testing was performed using 2 ARCHITECT i2000SR instruments, 3 reagent lots, 2 calibrator lots, and 1 control lot.

One calibrator lot was paired with one reagent lot; the second calibrator lot was paired with the other reagent lots. A calibration per reagent lot was performed on each instrument by testing the calibrators in replicates of 2.

The samples were tested in a minimum of 2 replicates (from separate sample cups) 2 times per day (separated by a minimum of 2 hours) for a total of 20 testing days.

The within-laboratory (total) imprecision (within-run, between-run, and between-day) across reagent lots on one representative instrument for the ARCHITECT 25-OH Vitamin D assay was:

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| | | | Within-Run | | Between-Run | | Between-Day | | Within-
Laboratory
(Total) | |
|----------------|-----|-----------------|------------|-----|-------------|-----|-------------|-----|----------------------------------|-----|
| Sample | N | Mean
(ng/mL) | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| Low Control | 358 | 20.6 | 0.44 | 2.1 | 0.17 | 0.8 | 0.49 | 2.4 | 0.68 | 3.3 |
| Medium Control | 358 | 40.6 | 0.82 | 2.0 | 0.38 | 0.9 | 0.84 | 2.1 | 1.23 | 3.0 |
| High Control | 360 | 77.3 | 1.81 | 2.3 | 0.53 | 0.7 | 2.00 | 2.6 | 2.75 | 3.6 |
| Panel A | 358 | 5.3 | 0.24 | 4.5 | 0.11 | 2.1 | 0.26 | 4.8 | 0.37 | 6.9 |
| Panel B | 360 | 10.0 | 0.28 | 2.8 | 0.13 | 1.3 | 0.29 | 2.9 | 0.42 | 4.2 |
| Panel C | 359 | 21.1 | 0.41 | 1.9 | 0.22 | 1.1 | 0.49 | 2.3 | 0.67 | 3.2 |
| Panel D | 359 | 30.5 | 0.63 | 2.1 | 0.47 | 1.6 | 0.51 | 1.7 | 0.94 | 3.1 |
| Panel E | 358 | 72.4 | 1.53 | 2.1 | 0.61 | 0.8 | 1.56 | 2.2 | 2.26 | 3.1 |
| Panel F | 360 | 110.6 | 2.97 | 2.7 | 0.00 | 0.0 | 3.09 | 2.8 | 4.29 | 3.9 |
| Panel G | 359 | 153.1 | 5.91 | 3.9 | 1.84 | 1.2 | 3.10 | 2.0 | 6.93 | 4.5 |

The ARCHITECT 25-OH Vitamin D assay demonstrated acceptable precision. Samples at concentrations less than 8.0 ng/mL met the requirement of an SD of ≤ 0.8 ng/mL. Samples at concentrations > 8.0 ng/mL met the requirement of 100 ng/mL

C-3-epimer- of 25-OH vitamin D3 (OHD3) at ≥ 100 ng/mL ●
. C-3-epimer- of 25-OH vitamin D2 (OHD2) at ≥ 100 ng/mL
. 1,25-(OH)2-vitamin D3 at ≥ 100 ng/mL
1,25-(OH)2-vitamin D2 at ≥ 100 ng/mL .

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. 24,25-(OH)2-vitamin D3 at > 20 ng/mL
24,25-(OH)2-vitamin D2 at ≥ 20 ng/mL
. Paricalcitol (Zemplar) at ≥ 24 ng/mL

The potential cross-reactants were evaluated at three analyte levels (20 ng/mL, 30 ng/mL, and 40 ng/mL), bracketing the medical decision points.

Serum samples at these concentrations were obtained and each sample was divided into 2 aliquots for each potential cross-reactant: one aliquot for the test sample and one aliquot for the reference sample.

Each sample was tested in a minimum of 12 replicates using 1 lot each of reagents, calibrators, and controls on 1 ARCHITECT i2000SR instrument.

The % cross-reactivity across the three analyte levels (20 ng/mL, 30 ng/mL, and 40 ng/mL) was determined:

| Cross-Reactant | Concentration
(ng/mL) | Maximum
% Cross-Reactivity* |
|------------------------------|--------------------------|--------------------------------|
| Vitamin D3 (Cholecalciferol) | 100 | 0.8% |
| Vitamin D2 (Ergocalciferol) | 100 | 0.4% |
| C-3-epimer- of 25-OHD3 | 100 | 1.3% |
| C-3-epimer- of 25-OHD2 | 100 | 0.8% |
| 1,25-(OH)2-vitamin D3 | 100 | 0.1% |
| 1,25-(OH)2-vitamin D2 | 100 | -0.4% |
| Paricalcitol (Zemplar) | 24 | 0.6% |

| Cross-Reactant | Concentration
(ng/mL) | % Cross-Reactivity |
|------------------------|--------------------------|--------------------|
| 24,25-(OH)2-vitamin D3 | 20 | 101.9% to 189.2% |
| 24,25-(OH)2-vitamin D2 | 20 | 71.4% to 114.2% |

Specificity - 25-OH Vitamin D3 Cross-Reactivity

A study was performed to evaluate the ARCHITECT 25-OH Vitamin D3 target analyte reactivity based on guidance from CLSI document EP7-A2.

The target analyte (25-OH vitamin D3) was tested at three analyte levels (20 ng/mL, 30 ng/mL, and 40 ng/mL), which bracketed the medical decision points.

Maximum % cross-reactivity 500 mg/dL. A triglyceride concentration of 800 mg/dL resulted in -13.8%, -10.2%, and -17.5% bias in results for 25-OH vitamin D concentration at approximately 20 ng/mL, 30 ng/mL, and 40 ng/mL 25-OH vitamin D, respectively.

Interference: Rheumatoid Factor and Heterophilic Antibody

Potential interference from rheumatoid factor (RF) and heterophilic antibody (i.e., goat anti-rabbit antibodies [GARA]) was evaluated based on guidance from the CLSI document EP7-A2.

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A 25-OH vitamin D stock solution was prepared by dissolving and diluting 25-hydroxyvitamin D3 (monohydrate) in ethanol, and then diluting further in vitamin D depleted human serum to obtain a final concentration of 2,000 ng/mL.

Samples were prepared at three analyte levels (20 ng/mL, 30 ng/mL, and 40 ng/mL) which bracket the medical decision points. The 20 ng/mL sample was prepared by pooling normal human serum. The 30 ng/mL and 40 ng/mL samples were prepared by supplementing normal human serum pools with the 25 OH vitamin D stock solution.

Each sample was divided into 2 aliquots: one aliquot for the test sample and one aliquot for the reference sample.

. The RF test sample was supplemented with RF stock solution with isotonic saline to a target RF concentration of ≥ 800 IU/mL. The RF reference sample was prepared by adding isotonic saline (equal to the volume of RF stock solution added to the test sample) to the reference aliquot.
. The GARA test sample was supplemented with GARA stock solution with ARCHITECT 25-OH Vitamin D Calibrator A to a target GARA concentration of > 1 ug/mL. The GARA reference sample was prepared by adding ARCHITECT 25-OH Vitamin D Calibrator A (equal to the volume of GARA stock solution added to the test sample) to the reference aliquot.

Each sample was tested in a minimum of 12 replicates using 1 lot each of reagents, calibrators, and controls on 1 ARCHITECT i2000SR instrument.

Across the three 25-OH vitamin D analyte levels (20.0 ng/mL, 30.0 ng/mL, and 40.0 ng/mL), the lower and upper one-sided 95% CL around the % difference ranged from:

. RF = -2.3% to 1.6%
. GARA = -2.7% to 3.9%

The ARCHITECT 25-OH Vitamin D assay is not susceptible to interference effects from the RF at ≤ 800 IU/mL or GARA at ≤ 1 ug/mL.

Interference: Other Medical Conditions

Potential interference from other medical conditions (pregnant females and hemodialysis patients) was evaluated based on guidance from CLSI document EP09-A3. Potentially interfering other medical conditions were evaluated using serum samples.

Interference effects were assessed by comparing the investigational results to the results generated with a commercially-available device that is not susceptible to interference

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from the medical conditions being evaluated (Liquid Chromatography - Tandem Mass Spectrometry [LC-MS/MS]). Specimens were sourced with concentrations that, at minimum, ranged from 20 ng/mL to 40 ng/mL 25-OH vitamin D.

For the investigational method, the specimens were tested internally using 2 lots of reagents, and 1 lot each of calibrators and controls on 2 ARCHITECT i2000SR instruments. For the comparator method. the specimens were tested at an external laboratory on 1 LC-MS/MS instrument.

Each specimen was tested in duplicate on the investigational method and at least once on the comparator method. Testing occurred over a minimum of 3 calendar days.

For specimens with 25-OH Vitamin D concentrations ranging from 20 ng/mL to 40 ng/mL, the mean % bias for each other medical condition is summarized in the following table.

| Category | N | LC-MS/MS
Concentration Range
(ng/mL) | Mean % Bias |
|----------------------------------|----|--------------------------------------------|-------------|
| Pregnant Females (1st Trimester) | 40 | 5.9–43.2 | 4.5% |
| Pregnant Females (1st Trimester) | 40 | 12.4–48.8 | -2.2% |
| Pregnant Females (1st Trimester) | 40 | 10.4–44.8 | 0.1% |
| Hemodialysis Patients | 44 | 4.1–61.2 | -15.3% |

The ARCHITECT 25-OH Vitamin D assay is not susceptible to interference effects from the following other medical conditions:

Pregnant females, 1st trimester .
Pregnant females, 2nd trimester .
Pregnant females, 3rd trimester .

The ARCHITECT 25-OH Vitamin D assay demonstrated a mean % bias of -15.3% with hemodialysis patient samples and therefore, is susceptible to interference effects from hemodialysis patients. Note: Published data demonstrated that results from patients undergoing hemodialysis may show a negative bias when tested with various automated 25-OH vitamin D assays when compared to LC-MS/MS. *

1 Heijboer AC, Blankenstein MA, Kema IP, Buijs MM. Accuracy of 6 Routine 25-Hydroxyvitamin D Assays; Influence of Vitamin D Binding Protein Concentration. Clinical Chemistry 2012; 58 (3):543-548.

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Method Comparison

A method comparison study was performed based on guidance from the CLSI document EP09-A3.

A minimum of 100 human serum specimens were evaluated with the ARCHITECT 25-OH Vitamin D assay and the comparator method (Isotope Dilution - Liquid Chromatography - Tandem Mass Spectrometry [ID-LC-MS/MS]).

Normal human serum specimens were chosen to span the measuring interval of the assay, and no more than 10% of specimens were spiked with 25-OH vitamin D stock solution.

For the investigational method, the samples were tested internally using 2 lots of reagents and 1 lot each of calibrators and controls on 2 ARCHITECT i2000SR instruments. For the ID-LC-MS/MS method, the samples were tested at an external reference laboratory using a minimum of 1 ID-LC-MS/MS.

Each sample was tested in a minimum of 2 replicates for the investigational method. Testing occurred over a minimum of 3 calendar days.

The Passing-Bablok regression slope was 1.02, the intercept was -0.99, and the correlation coefficient (r-value) was 0.99 for samples across the measuring interval when evaluating the first replicate of the ARCHITECT 25-OH Vitamin D assay to the comparator method result.

The method comparison data for the investigational method, ARCHITECT 25-OH Vitamin D (List No. 5P02), and the comparator method, ID-LC-MS/MS, was acceptable.

Tube Type Equivalency

A study was performed based on guidance from CLSI document EP7-A2 to evaluate whether specific blood collection tube types are suitable for use with the ARCHITECT 25-OH Vitamin D assay.

Samples were obtained from a specimen vendor from a minimum of 40 donors in the control tube type (serum plastic) and in the following evaluation tube types:

. serum separator tubes (SST)
. dipotassium EDTA
. tripotassium EDTA
. sodium heparin
lithium heparin powder ●

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plasma separator tubes (PST) – lithium heparin gel
The blood collection tubes from one individual constituted one donor set. The samples were processed according to the blood collection tube manufacturer's instructions.

Sample from each donor (in the control tube) was tested in replicates of 3 with the ARCHITECT 25-OH Vitamin D assay to determine the 25-OH vitamin D concentration.

The blood collection tubes (for no more than 20% of the donor sets) were supplemented with the 25-OH vitamin D stock solution to create samples that spanned the measuring interval of the assay.

The samples from each sample set were tested in a minimum of 2 replicates using 1 lot each of reagents, calibrators, and controls on 2 ARCHITECT i2000SR instruments.

The tube types under evaluation, when compared to the control tube type, had lower and upper one-sided 95% CL around the % difference within ± 10% across the measuring interval of the assay.

Each evaluation tube type was compared to the control tube type, and the results were evaluated using the Passing-Bablok regression method. The equations and correlation coefficients (r) are summarized in the following table.

| | Serum
Specimen | Plasma Specimen | | | | |
|--------------------|-------------------|---------------------|----------------------|-------------------|------------------------------|----------------------------|
| | SST | Dipotassium
EDTA | Tripotassium
EDTA | Sodium
Heparin | Lithium
Heparin
Powder | PST Lithium
Heparin Gel |
| N | 51 | 51 | 51 | 51 | 51 | 51 |
| Passing-
Bablok | y=0.99x+0.04 | y=0.93x+0.76 | y=0.92x+0.83 | y=0.94x+0.84 | y=0.94x+0.90 | y=0.93x+1.09 |
| r value | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 |

The following blood collection tube types are acceptable for use with the ARCHITECT 25-OH Vitamin D assay:

. serum plastic
serum separator tubes (SST)
. dipotassium EDTA
. tripotassium EDTA
. sodium heparin

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. lithium heparin powder
. plasma separator tubes (PST) – lithium heparin gel

Specimen Stability

A study was performed to evaluate serum and plasma specimens when subjected to various conditions (room temperature storage, 2 to 8℃ storage, and freeze/thaw) and tested with the ARCHITECT 25-OH Vitamin D assay.

A total of 14 serum specimens and 14 plasma specimens were obtained from a specimen vendor in serum (plastic, no additive), serum separator (plastic, additive), and tripotassium EDTA (plastic) blood collection tubes.

The specimens in each of the tube types were tested in a minimum of 2 replicates using 1 lot each of reagents and calibrators, 2 lots of controls, and 2 ARCHITECT i2000SR instruments.

The ARCHITECT 25-OH Vitamin D assay had lower and upper one-sided 95% CL around the % difference of ± 10% when comparing baseline control specimens tested within 8 hours from draw to the same speciments stored at the following conditions:

. 2 to 8°C for > 12 days (both on and off the clot)
. approximately 22°C or 30°C for ≥ 72 hours
≥ 4 freeze/thaw cycles after being stored at 2 to 8°C for ≥ 12 days off the clot .

Specimens stored at 2 to 8℃ (on or off the clot/cells) for up to 12 days, specimens stored at room temperature (approximately 22 to 30°C) for up to 72 hours, and specimens subjected to 4 freeze thaw cycles after being stored at 2 to 8°C off the clot for up to 12 days are acceptable for use in the ARCHITECT 25-OH Vitamin D assay.

Manual Dilution

A study was performed to demonstrate that the ARCHITECT 25-OH Vitamin D assay can recover manually-diluted samples.

A minimum of 13 unique donor specimens were obtained. The specimens were spiked with 25-OH vitamin D stock solution to create high samples with 25-OH vitamin D concentrations of approximately 180 ng/mL, 230 ng/mL, 280 ng/mL, and 320 ng/mL.

Test samples were prepared by diluting the high samples with ARCHITECT 25-OH Vitamin D Calibrator A (List No. 5P02A) at dilution factors of 1:2, 1:3, and 1:4.

The samples were tested in a minimum of 2 replicates using 1 lot each of reagents, calibrators, and controls on 1 ARCHITECT i2000SR instrument.

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Using a first replicate concentration analysis, the mean (or median) % recovery value was 96.8% for the 1:2 dilution factor, 97.1% for the 1:3 dilution factor, and 103.7% for the 1:4 dilution factor.

The ability of the ARCHITECT 25-OH Vitamin D assay to recover manually-diluted samples was demonstrated.

Measuring Interval Determination

The measuring interval for the ARCHITECT 25-OH Vitamin D assay has been determined to be 3.4 to 155.9 ng/mL (8.5 to 389.8 nmol/L).

The measuring interval is based on the acceptable performance of imprecision, linearity, limit of quantitation, and bias (based on the method comparison with ID-LC-MS/MS) on the ARCHITECT i2000SR instrument.

Precision data, including samples ranging from 5.2 to 142.2 ng/mL, support the lower (3.4 ng/mL) and upper limits (155.9 ng/mL) of the measuring interval.

The linear range was demonstrated to be from 3.4 to 155.9 ng/mL.

The highest observed LoQ was 2.4 ng/mL, which is below the lower limit of the measuring interval (3.4 ng/mL).

Method comparison with ID-LC-MS/MS was performed with samples ranging from 4.0 to 153.2 ng/mL on the ID-LC-MS/MS, which supports the ARCHITECT 25-OH Vitamin D measuring interval of 3.4 to 155.9 ng/mL.

Conclusion Drawn from Nonclinical Laboratory Studies

The results presented in this 510(k) premarket notification demonstrate that the candidate assay (ARCHITECT 25-OH Vitamin D [List No. 5P02]) performance is substantially equivalent to the predicate assay (ARCHITECT 25-OH Vitamin D, K110619).