Predicate Devices

Nichols Institute Human Growth Hormone Assay

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard bioluminescent immunoassay process involving chemical reactions, light measurement, and calibration curve plotting. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.

Therapeutic

No.
This device is an in vitro diagnostic product used for the quantitative determination of human growth hormone in serum, which aids in the diagnosis and treatment of disorders. It does not directly provide therapy.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the device is "an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland." This directly indicates its purpose as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical kit containing antibodies, tubes, and reagents, which are hardware components. While a luminometer is used to read the results and software is used for calculation, the core medical device is the immunoassay kit itself, which is not software-only.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum." and "The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use."

This clearly indicates that the device is intended for use outside of the body to diagnose conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use.

Product codes

CFL

Device Description

The AquaLite® hGH Bioluminescent Immunoassay Kit uses a mouse monoclonal anti-hGH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples or appropriate calibrators or controls, are pipetted (150 uL) into the precoated tubes. A sheep anti-hGH antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. hGH in the sample combines with the antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 120-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.

The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the hGH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the hGH calibrators is plotted against hGH concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to hGH concentration in ng/mL.

Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Serum

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical laboratories

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)

Sensitivity: The sensitivity or detection limit of the AquaLite® hGH Assay is 0.005 ng/mL. Sensitivity is determined by adding the mean signal of 20 replicates of the zero level calibrator plus two (2) standard deviations above this mean. The hGH concentration (ng/mL) associated with this calculated signal is defined as the sensitivity of the assay.
Specificity: The AquaLite® hGH Assay measures human growth hormone. Cross-reactivity with Prolactin (0.09-0.17%), hPL (

Regulation Number and Section

§ 862.1370 Human growth hormone test system.

(a)
Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

0

SEP 25 .997

millillel

EXHIBIT D

510(k) Summary For AquaLite® Human Growth Hormone Assay

1

510(k) SUMMARY

I. GENERAL INFORMATION

Trade or proprietary name - SeaLite Sciences, Inc. AquaLite® hGH Assay

Common or usual name - Bioluminescent immunoassay (BIA)

Classification name - FDA has classified human growth hormone test systems intended for the measurement of human growth hormone in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary glands. Class I devices (21 C.F.R. § 862.1370)

| Submitter's Name and Address: | Cathryn N. Cambria
Director, Regulatory Affairs and
Quality Assurance
SeaLite Sciences, Inc.
3000 Northwoods Parkway
Suite 200
Norcross, GA 30071
(800) 874-4471, ext. 227 |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | July 23, 1997 |
| Legally Marketed Device
To Which Claim Substantial
Equivalence: | Nichols Institute
Human Growth Hormone Assay |

II. INDICATIONS FOR USE

The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use.

2

DEVICE DESCRIPTION III.

The AquaLite® hGH Bioluminescent Immunoassay Kit uses a mouse monoclonal anti-hGH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples or appropriate calibrators or controls, are pipetted (150 uL) into the precoated tubes. A sheep anti-hGH antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. hGH in the sample combines with the antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 120-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.

The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the hGH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the hGH calibrators is plotted against hGH concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to hGH concentration in ng/mL.

Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

SUMMARY OF STUDIES AND TECHNOLOGICAL CHARACTERISTICS IV.

Studies on the AquaLite® hGH Assay were conducted at SeaLite Sciences. The results are summarized below:

Performance Characteristics

1. Sensitivity
  The sensitivity or detection limit of the AquaLite® hGH Assay is 0.005 ng/mL. Sensitivity is determined by adding the mean signal of 20 replicates of the zero level calibrator plus two (2) standard deviations above this mean. The hGH concentration (ng/mL) associated with this calculated signal is defined as the sensitivity of the assay.

3

Specificity 2.

The AquaLite® hGH Assay measures human growth hormone. The following human hormones were supplied by the World Health Organization's National Institute for Biological Standards and Control (London, England). Aliquots of these preparations were diluted to the following levels in human serum and assayed. Percent cross-reactivity (%) is reported below:

| SUBSTANCE | WHO/NIBSC
LOT NUMBER | TESTED AT | CROSS-
REACTIVITY |
|-----------|-------------------------|-------------------------------|----------------------|
| Prolactin | 3rd I.S. 84/500 | 500 ng/mL
1,000 ng/mL | 0.09
0.17 |
| hPL | 1st IRP 73/545 | 10,000 ng/mL
100,000 ng/mL |