(55 days)
Not Found
No
The document describes calibrators and controls for an in vitro diagnostic system, which are chemical reagents used for calibration and quality control, not software or algorithms that would typically incorporate AI/ML. There is no mention of AI, ML, image processing, or data analysis beyond standard quantitative determination.
No
The device is an in vitro diagnostic product used for calibration and quality control of a system measuring different proteins. It is not used for treating or diagnosing patients directly, but rather for ensuring the accuracy of lab tests.
No
The provided text describes calibrators and controls used for the calibration and quality control of a diagnostic system, not the diagnostic device itself. They are "in vitro diagnostic product for the calibration of the Dimension Vista System" and "intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System". These products ensure the accuracy of a diagnostic test, but they are not the device that performs the diagnosis.
No
The device description clearly states that the products are "liquid human serum based products," indicating they are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the Dimension Vista® Protein 1 Calibrator and the Dimension Vista® Protein 1 Control products are "in vitro diagnostic product[s]".
Furthermore, the description of their use for calibration and quality control in the quantitative determination of various proteins and substances within a laboratory setting aligns perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Dimension Vista® Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for: a - Acid Glycoprotein (A1AG) a - Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoqlobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Dimension Vista® Protein 1 Control L
PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a - Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoqlobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Dimension Vista® Protein 1 Control M and H
PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) İmmunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Product codes (comma separated list FDA assigned to the subject device)
JIX, JJY
Device Description
Dimension Vista® Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a - acid glycoprotein immunoglobulin G a - antitrypsin immunogiobulin G Subclass 1 B »- microalobulin immunoglobulin G Subclass 2 C3 complement immunoglobulin G Subclass 3 C4 complement immunoglobulin G Subclass 4 ceruloplasmin immunoqlobulin M haptoglobin prealbumin hemopexin retinol binding protein homocysteine soluble transferrin receptor immunoglobulin A transferrin immunoglobulin E
Dimension Vista® Protein 1 Control L
Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing :
- a-acid glycoprotein a 1-antitrypsin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoqlobulin G immunoglobulin G Subclass 1 immunoglobulin G Subclass 2 immunoqlobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin
Dimension Vista® Protein 1 Control M and H
Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing :
- a1-acid glycoprotein a-antitrypsin B2-microglobulin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoglobulin G immunoqlobulin G Subclass 1 immunoglobulin G Subclass 2 immunoglobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin
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)
Not Found
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.
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1 and Dimension Vista™ Protein 1 Control 510(k) Notification
SEP 1 1 2007
510(k) Summary for Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L, M and H
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:
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
35041 Marburg, Germany |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, Delaware 19714-6101
Attn: A. Kathleen Ennis
Tel: 302-631-9352
Fax: 302-631-6299 |
| Preparation date: | June 8, 2007 |
| Device Name: | Dimension Vista® Protein 1 Calibrator
Dimension Vista® Protein 1 Control L
Dimension Vista® Protein 1 Control M
Dimension Vista® Protein 1 Control H |
Classification: Class II; Class I Product Code: JIX: JJY Panel: Clinical Chemistry (75)
3. Identification of the Legally Marketed Device:
| Dimension Vista® Protein 1 Calibrator | K063663 |
|---|---|
| Dimension Vista® Protein 1 Control L | K063663 |
| Dimension Vista® Protein 1 Control M | K063663 |
| Dimension Vista® Protein 1 Control H | K063663 |
1
4. Device Descriptions:
Dimension Vista® Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a - acid glycoprotein immunoglobulin G a - antitrypsin immunogiobulin G Subclass 1 B »- microalobulin immunoglobulin G Subclass 2 C3 complement immunoglobulin G Subclass 3 C4 complement immunoglobulin G Subclass 4 ceruloplasmin immunoqlobulin M haptoglobin prealbumin hemopexin retinol binding protein homocysteine soluble transferrin receptor immunoglobulin A transferrin immunoglobulin E
Dimension Vista® Protein 1 Control L
Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing :
- a-acid glycoprotein a 1-antitrypsin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoqlobulin G immunoglobulin G Subclass 1 immunoglobulin G Subclass 2 immunoqlobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin
Dimension Vista® Protein 1 Control M and H
Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing :
- a1-acid glycoprotein a-antitrypsin B2-microglobulin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoglobulin G immunoqlobulin G Subclass 1 immunoglobulin G Subclass 2 immunoglobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin
2
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1
and Dimension Vista™ Protein 1 Control 510(k) Notification
5. Device Intended Uses:
Dimension Vista® Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:
a - Acid Glycoprotein (A1AG) a - Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoqlobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Dimension Vista® Protein 1 Control L
PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:
a - Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoglobulin G (IGG) Immunoqlobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Dimension Vista® Protein 1 Control M and H
PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:
a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) İmmunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
3
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1 and Dimension Vista™ Protein 1 Control 510(k) Notification
Medical device to which equivalence is claimed and comparison information: 6.
The Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L, M and H modified to include hemopexin (HPX), immunoglobulin G subclass 1 (IGG1), immunoglobulin G subclass 2 (IGG2), immunoqlobulin G subclass 3 (IGG3), immunoglobulin G subclass 4 (IGG4), and retinol binding protein (RBP) are substantially
equivalent in intended use to the current Dimension Vista Protein (RBP) are substantia Dimension Vista® Protein 1 Control L, M and H (K063663). The modified Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H like the current products are intended to be used for the calibration of human protein assays and for use as assayed intralaboratory quality controls respectively, on the Dimension® Vista System.
7. Conclusion
The modified Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L., M and H, are substantially equivalent to the legally marketed devices based on the information described above.
4
Image /page/4/Picture/13 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted with four curved lines that resemble wings or stylized snakes, and the text is in a sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. c/o Ms AnnaMarie Kathleen Ennis Regulatory Affairs and Compliance Specialist Glasgow Site P.O. Box 6101 Newark, DE 19714-6101
SEP 1 1 2007
Re: K071980
Trade/Device Name: Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control H Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control L Regulation Number: 21 CFR 862.1150
Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: July 18, 2007 Received: July 18, 2007
Dear Ms. Ennis:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
5
Page 2 -
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Robert L. Beckerf
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications Statement
Device Name: Dimension Vista Protein 1 Calibrator
Indications for Use: Ko 1990
Dimension Vista® Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista" System for:
a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) Bo-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M Char
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K07/1890
7
Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification
Indications Statement
Device Name: Dimension Vista Protein 1 Control L
Indications for Use:
011980
Dimension Vista® Protein 1 Control L
PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of
a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnostics
Device Evaluation and Safety
51000 0 71980
8
Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification
Indications Statement
Device Name: Dimension Vista® Protein 1 Control M
Indications for Use:
Image /page/8/Picture/4 description: The image contains a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'o', followed by the number '7'. After that, the numbers '1980' are written. The handwriting appears to be somewhat rough or stylized.
Dimension Vista® Protein 1 Control M
PROT1 CON M is an assayed, mid-level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:
a1-Acid Glycoprotein (A1AG) a3-Antitrypsin (A1AT) Bo-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunogiobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria In Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko7/980
9
Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification
Indications Statement
Device Name: Dimension Vista® Protein 1 Control H
Indications for Use:
Dimension Vista® Protein 1 Control H
PROT1 CON H is an assaved, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of
a1-Acid Glycoprotein (A1AG) a - Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoqlobulin E (IGE)
Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Prescription Use × (Per 21 CFR 801 Subpart D)
Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M Char
Division Sign-Off
In Vitro Dicto רות האחרא וונ
510(k) Ko71980