(15 days)
No
The summary describes a standard chemiluminescent immunoassay for measuring vitamin B12. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is a well-established laboratory technique.
No.
This device is an in vitro diagnostic (IVD) device used to quantitatively determine vitamin B12 levels, which aids in diagnosis and treatment monitoring, but it does not directly perform therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption."
No
The device description clearly outlines physical components including reagent kits, calibrator kits, and control kits, which are not software. The device is a chemiluminescent microparticle immunoassay, which is a laboratory-based assay requiring physical reagents and instrumentation (the ARCHITECT i System).
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 measurements obtained by this device are used "in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This clearly indicates that the device is intended to be used in vitro (outside the body) to provide information for diagnostic purposes.
- Device Description: The description details a "chemiluminescent microparticle immunoassay (CMIA) technology" used to determine the presence of B12 in human serum and plasma. This is a laboratory-based test performed on biological samples.
- Components: The device includes reagents, calibrators, and controls, which are typical components of IVD assays used in a laboratory setting.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The ARCHITECT B12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum and plasma using the ARCHITECT B12 Reagent Kit.
The ARCHITECT B12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma when using the ARCHITECT B12 Reagent Kit.
Product codes
CDD, JIT, JJX
Device Description
The ARCHITECT B12 assay is a two-step assay with an automated sample pretreatment, for determining the presence of B12 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.
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)
a. Precision: A 20-day precision study was conducted to evaluate the precision performance of the ARCHITECT B12 assay using plasma panels. This study was based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP5-A2. Low, Medium, and High lithium heparin plasma panels were tested. Testing was performed using 2 lots of reagents, and 1 lot each of calibrators and controls on 2 ARCHITECT i 2000sR instruments. The 3 plasma panel levels were each tested in replicates of 3, twice daily (a minimum of 2 hours apart), on each of 20 days, using 2 reagent lots on 2 ARCHITECT i 2000sR instruments. The data demonstrated acceptable total (within-laboratory) imprecision of
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
0
KI21314
MAY 1 7 2012
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.
1. Applicant Name
Darla Abano, Regulatory Affairs Project Manager Regulatory Affairs Abbott Laboratories Diagnostics Division Dept 9V6, AP5N-2 100 Abbott Park Road Abbott Park, IL 60064
2. Device Name
Reagents
Classification Name: Vitamin B12 test system Trade Name: ARCHITECT B12 Common Name: B12 Governing Regulation: 862.1810 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CDD
Calibrators
Classification Name: Calibrator Trade Name: ARCHITECT B12 Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry · Product Code: JIT
Controls
Classification Name: Quality Control Material (assayed and unassayed) Trade Name: ARCHITECT B12 Controls (Low, Medium, and High) Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX
1
3. Predicate Device
Abbott ARCHITECT B12 (K110579).
4. Intended Use of Device
The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma on the ARCHITECT i System.
5. Description of Device
The ARCHITECT B12 assay is a two-step assay with an automated sample pretreatment, for determining the presence of B12 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.
ARCHITECT B12 Reagent Kit
The ARCHITECT B12 Reagent Kit consists of 100 (1 x 100) or 500 (1 x 500) tests. Each kit contains 1 bottle each of the following reagents:
- ARCHITECT B12 Microparticles 1 bottle (6.6 mL per 100-test bottle/27.0 mL per . 500-test bottle) intrinsic factor (porcine) coated microparticles in borate buffer with protein (bovine) stabilizers. Minimum Concentration: 0.1% solids. Preservative: antimicrobial agents.
- ARCHITECT B12 Conjugate 1 Bottle (5.9 mL per 100-test bottle/26.3 mL per . 500-test bottle) B12 acridinium-labeled conjugate in MES buffer. Minimum concentration: 0.7 ng/mL. Preservative: ProClin 300.
- ARCHITECT B12 Assay Diluent 1 Bottle (10.0 mL per 100-test bottle/51.0 mL . per 500-test bottle) B12 Assay Diluent containing borate buffer with EDTA. Preservative: antimicrobial agents.
- ARCHITECT B12 Pre-Treatment Reagent 1 1 Bottle (27.0 mL per 100-test � bottle/50.4 mL per 500-test bottle) B12 Pre-Treatment Reagent 1 containing 1.0 N sodium hydroxide with 0.005% potassium cyanide.
- ARCHITECT B12 Pre-Treatment Reagent 2 1 Bottle (5.5 mL per 100-test . bottle/25.9 mL per 500-test bottle) B12 Pre-Treatment Reagent 2 containing alpha monothioglycerol and EDTA.
2
- ARCHITECT B12 Pre-Treatment Reagent 3 1 Bottle (5,5 mL per 100-test bottle/25.9 mL per 500-test bottle) B12 Pre-Treatment Reagent 3 containing cobinamide dicyanide in borate buffer with protein (avian) stabilizers. Preservative: sodium azide.
ARCHITECT B12 Calibrator Kit
Each ARCHITECT B12 Calibrator Kit contains 6 Bottles (4 mL each) of ARCHITECT B12 Calibrators (1 bottle each of Calibrators A – F). Preservative: sodium azide. Calibrator A contains borate buffer with protein stabilizer (human albumin). Calibrators B – F contain gravimetrically prepared cyanocobalamin in borate buffer with protein stabilizer (human albumin). Calibrators have the following approximate concentrations: 0, 110, 250, 500, 1000, and 2000 pg/mL.
ARCHITECT B12 Control Kit
Each ARCHITECT B12 Control Kit contains 3 bottles (8 mL each) of ARCHITECT B12 Controls (1 bottle of low control, 1 bottle of medium control, and 1 bottle of high control). Preservative: sodium azide. The Low and High Controls (Control L and Control H) contain cyanocobalamin in borate buffer with protein stabilizer (human albumin). The Medium Control (Control M) contains cyanocobalamin in human serum. Controls have the following approximate concentrations: Low Control, 251 pg/mL; Medium Control, 454 pg/mL; and High Control, 915 pg/mL.
6. Comparison of Technological Characteristics
The ARCHITECT B12 assay utilizes chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative determination of vitamin B12 in human serum and plasma. The Abbott ARCHITECT B12 (LN7K61) assay (K110579) utilizes CMIA technology for the quantitative determination of vitamin B12 in human serum.
3
| Reagents: | ||
|---|---|---|
| Characteristics | Submission Device | |
| ARCHITECT B12 | ||
| (Plasma Claim) | Predicate Device | |
| ARCHITECT B12 | ||
| (K110579) | ||
| Intended Use and | ||
| Indications for Use | The ARCHITECT B12 assay | |
| is a chemiluminescent | ||
| microparticle Intrinsic Factor | ||
| assay for the quantitative | ||
| determination of vitamin B12 | ||
| in human serum and plasma | ||
| on the ARCHITECT i System. |
Measurements obtained by
this device are used in the
diagnosis and treatment of
anemias of gastrointestinal
malabsorption. | The ARCHITECT B12 assay
is a chemiluminescent
microparticle Intrinsic Factor
assay for the quantitative
determination of vitamin B12
in human serum on the
ARCHITECT i System.
Measurements obtained by
this device are used in the
diagnosis and treatment of
anemias of gastrointestinal
malabsorption. |
| Platform | Same as predicate. | ARCHITECT i System
(immunoassay analyzer) |
| Methodology | Same as predicate. | Chemiluminescence |
| Specimen type | Serum and Plasma (lithium
heparin) | Serum |
| Calibration Range | Same as predicate. | 0-2,000 pg/mL |
| Expected Values | Same as predicate. | Normal range: US:
195-886 pg/mL |
| Measuring Interval | Same as predicate. | 146-2000 pg/mL |
.
:
:
. . . . . . . .
. . . .
:
:
. .
: : : : : : .
..............................................................................................................................................................................
4
| Characteristics | Submission Device
ARCHITECT B12
(Plasma Claim) | Predicate Device
ARCHITECT B12
(K093401) |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use and
Indications for Use -
Calibrators | The ARCHITECT B12
Calibrators are used to
calibrate the ARCHITECT
i System when the system is
used for the quantitative
determination of vitamin B12
in human serum and plasma
using the ARCHITECT B12
Reagent Kit. | The ARCHITECT B12 Calibrators
are used to calibrate the
ARCHITECT i System when the
system is used for the quantitative
determination of vitamin B12 in
human serum using the
ARCHITECT B12 Reagent Kit. |
| Calibrator Levels | Same as predicate. | 6 levels
A: 0 pg/mL,
B: 110 pg/mL
C: 250 pg/mL
D: 500 pg/mL
E: 1,000 pg/mL
F: 2,000 pg/mL |
| Standardization/
Traceability | Same as predicate. | Abbott manufactures B12 internal
standards gravimetrically using
cyancobalamin (USP Reference
Standard). The B12 calibrators are
manufactured and tested against
these internal standards. |
:
.
:
:
.
.
:
.
.
. . . . . . . . .
.
.
. .
5
| Controls: | ||
|---|---|---|
| Characteristics | Submission Device | |
| ARCHITECT B12 | ||
| (Plasma Claim) | Predicate Device | |
| ARCHITECT B12 | ||
| (K093401) | ||
| Intended use and | ||
| Indications for Use - | ||
| Controls | The ARCHITECT B12 | |
| Controls are used for the | ||
| estimation of test precision | ||
| and the detection of | ||
| systematic analytical | ||
| deviations of the | ||
| ARCHITECT i System when | ||
| used for the quantitative | ||
| determination of vitamin B12 | ||
| in human serum and plasma | ||
| when using the ARCHITECT | ||
| B12 Reagent Kit. | The ARCHITECT B12 Controls | |
| are used for the estimation of test | ||
| precision and the detection of | ||
| systematic analytical deviations of | ||
| the ARCHITECT i System when | ||
| used for the quantitative | ||
| determination of vitamin B12 in | ||
| human serum when using the | ||
| ARCHITECT B12 Reagent Kit. | ||
| Control Matrix and | ||
| Components | Same as predicate. | Control L and H contain |
| cyanocobalamin in borate buffer | ||
| with protein stabilizers (human | ||
| albumin). | ||
| Preservative: sodium azide | ||
| Control M contains | ||
| cyanocobalamin in human serum. | ||
| Preservative: sodium azide | ||
| Control Levels | Same as predicate. | 3 levels |
| Targets: | ||
| Low: 251 pg/mL | ||
| Medium: 454 pg/mL | ||
| High: 915 pg/mL |
:
.
.
the submit and the submit of the subject of the subject of
:
:
6
7. Summary of Nonclinical Performance
a. Precision
A 20-day precision study was conducted to evaluate the precision performance of the ARCHITECT B12 assay using plasma panels. This study was based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP5-A2. Low, Medium, and High lithium heparin plasma panels were tested. Testing was performed using 2 lots of reagents, and 1 lot each of calibrators and controls on 2 ARCHITECT i 2000sR instruments. The 3 plasma panel levels were each tested in replicates of 3, twice daily (a minimum of 2 hours apart), on each of 20 days, using 2 reagent lots on 2 ARCHITECT i 2000sR instruments.
The calibration curve generated for each reagent lot was stored on each instrument for the duration of the study.
The data demonstrated acceptable total (within-laboratory) imprecision of