(75 days)
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No
The summary describes a system for collecting and preparing blood samples for analysis, not the analysis method itself. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is for in vitro diagnostic use to collect blood samples for A1c determination, which is used for monitoring, not treating, a disease.
No
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods for in vitro diagnostic use. It provides materials for blood sample collection and preparation, which are then analyzed by separate hemoglobin testing systems (VARIANT™ II or D-10™). The device itself does not perform the diagnostic measurement or analysis; it is a sample collection and preparation system.
No
The device description explicitly lists physical components such as sample preparation vials, capillaries, capillary holders, and labels, indicating it is a hardware-based system for sample collection and preparation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Function: The device is intended for the collection of human whole blood for the determination of hemoglobin A1c using specific laboratory methods (Bio-Rad HPLC methods). This process of analyzing biological samples outside of the body to obtain diagnostic information is the core definition of an in vitro diagnostic device.
- Purpose: The measurement of hemoglobin A1c is used for "monitoring long-term glucose control in individuals with diabetes mellitus," which is a diagnostic and monitoring purpose.
N/A
Intended Use / Indications for Use
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
For in vitro diagnostic use.
The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JKA
Device Description
Each Hemoglobin Capillary Collection System (HCCS) contains a combination of the following components (quantity is dependent upon kit size):
-
Sample Preparation Vials: clear microvials with blue pierceable caps, each contains 1.5 mL of the HCCS reagent.
-
Capillaries: plastic capillaries (5 uL) in a dispenser.
-
Capillary Holder: holder for manipulating the capillaries.
-
Labels: to label prepared samples.
The HCCS provides the necessary materials for a professional user to collect and prepare whole blood samples (capillary or venous blood) for analysis with the VARIANT™ II Hemoglobin A1c Program run on the VARIANT™ II Hemoglobin Testing System or the D-10™ Hemoglobin A1c Program run on the D-10™ Hemoglobin Testing System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Professional user
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study: A study was conducted at an external site to determine if there is a significant difference in the hemoglobin A1c values of capillary samples collected and prepared with the Hemoglobin Capillary Collection System (HCCS) versus the values obtained from the corresponding venous whole blood samples when analyzed with the VARIANT™ II Hemoglobin A1c Program on the VARIANT™ II Hemoglobin Testing System and with the D-10™ Hemoglobin A1c Program on the D-10™ Hemoglobin Testing System. One HCCS capillary sample and one venous EDTA primary tube sample were collected from each patient.
Key results: The study showed no significant difference in hemoglobin A1c values for whole blood samples prepared with HCCS versus whole blood samples diluted with predicate Wash/Diluent Solutions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
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Summary of Safety and Effectiveness ... ...
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Submitter:
Bio-Rad Laboratories, Inc., Clinical Systems Division, 4000 Alfred Nobel Drive, Hercules. California 94547
Phone: (510) 741-6114; Fax: (510) 741-3954
Contact Person:
Jolene Bartilson, Regulatory Affairs Representative
Device Name:
Hemoglobin Capillary Collection System (HCCS)
Classification Name:
Blood specimen collection device, JKA
Assay, Glycosylated hemoglobin, LCP
Predicate Devices:
VARIANT™ II Hemoglobin A1c Program, Bio-Rad Laboratories, Inc., K070452 -Wash/Diluent Solution
D-10TM Hemoglobin A1c Program, Bio-Rad Laboratories, Inc., K031043 - Wash/Diluent Solution
Intended Use:
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
For in vitro diagnostic use.
Indications For Use:
The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
1
Description of the Device:
Each Hemoglobin Capillary Collection System (HCCS) contains a combination of the following components (quantity is dependent upon kit size):
-
Sample Preparation Vials: clear microvials with blue pierceable caps, each contains 1.5 mL of the HCCS reagent.
-
Capillaries: plastic capillaries (5 uL) in a dispenser.
-
Capillary Holder: holder for manipulating the capillaries.
-
Labels: to label prepared samples.
The HCCS provides the necessary materials for a professional user to collect and prepare whole blood samples (capillary or venous blood) for analysis with the VARIANT™ II Hemoglobin A1c Program run on the VARIANT™ II Hemoglobin Testing System or the D-10™ Hemoglobin A1c Program run on the D-10™ Hemoglobin Testing System.
Technical Characteristics Compared to the Predicates:
The Hemoglobin Capillary Collection System (HCCS) reagent is intended to dilute whole blood samples in the same way that the predicate Wash/Diluent Solutions of the VARIANT™ II Hemoglobin A1c Program and D-10™ Hemoglobin A1c Program are used to dilute whole blood samples; in preparation for the percent determination of hemoglobin A I c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The similarities and differences between the HCCS and the predicates are summarized in the following table:
| Characteristic | New Device:
Hemoglobin
Capillary
Collection System
(HCCS) | Predicate Device:
VARIANT™ II
HbA1c Program,
Wash/Diluent Solution
(K070452) | Predicate Device: D-
10™ HbA1c
Program,
Wash/Diluent
Solution (K031043) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Hemoglobin
Capillary
Collection System
(HCCS) is intended
for the collection of
human whole blood
for the percent
determination of
hemoglobin A1c
using Bio-Rad
HPLC methods. For | The Bio-Rad
VARIANT II
Hemoglobin A1c
Program is intended for
the percent
determination of
hemoglobin A1c in
human whole blood
using ion-exchange
high performance liquid
chromatography | The Bio-Rad D-10
Hemoglobin A1c
Program is intended for
the percent
determination of
hemoglobin A1c in
human whole blood
using ion-exchange
high-performance
liquid chromatography
(HPLC). The Bio-Rad |
| | in vitro diagnostic
use. | (HPLC). The Bio-Rad
VARIANT II
Hemoglobin A1c
Program is intended for
Professional Use Only. | D-10 Hemoglobin A1c
Program is intended for
Professional Use Only. |
| Indications
For Use | Measurement of
percent hemoglobin
A1c is effective in
monitoring long-
term glucose
control in
individuals with
diabetes mellitus. | Measurement of
percent hemoglobin
A1c is effective in
monitoring long-term
glucose control in
individuals with
diabetes mellitus. | Measurement of
percent hemoglobin
A1c is effective in
monitoring long-term
glucose control in
individuals with
diabetes mellitus. |
| Formulation | Aqueous solution
of EDTA and
potassium cyanide. | Deionized water with