K Number

Device Name

SEALITE SCIENCES, INC. AQUALITE PROLACTIN

Manufacturer

SEALITE SCIENCES, INC.

Date Cleared

1997-02-20

(34 days)

Product Code

CFT

Regulation Number

862.1625

Intended Use

The AquaLite® Prolactin Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Prolactin assay) is intended to be used in clinical laboratories for the quantitative determination of human prolactin levels in sera and plasma. The AquaLite® Prolactin assay is for in vitro diagnostic use.

Device Description

The AquaLite® Prolactin Bioluminescent Immunoassay Kit uses a mixture of mouse monoclonal and rabbit polyclonal with anti-prolactin activity that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the pre-coated tubes. Anti-prolactin conjugate consisting of mouse monoclonal antibody covalently linked to AquaLite® (150µL) is then added to the tubes. The conjugate uses the photoprotein, AquaLite® (recombinant aequorin: U.S. Patent Nos. 5,422,266 and 5,486,455) which is covalently linked to an anti-prolactin polyclonal antibody. Prolactin in the sample simultaneously combines with polyclonal 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 60-minute incubation period at room temperature (18° to 25°C) 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. An injected calcium trigger solution causes AquaLite® to oxide its self-contained luciferin molecule. This reaction produces a twosecond flash of light at 469 nm, which is measured by the luminometer. The intensity of the light is directly proportional to the concentration of the prolactin in the sample. To calculate results, the luminometer uses a cubic spline curve fit applied to a logit-log transformation of the light intensity (in relative light units, RLU) of the prolactin calibrators versus prolactin 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Chiron Diagnostics ACS 180 Prolactin assay

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard bioluminescent immunoassay using chemical reactions and a luminometer for measurement. The calculation of results uses a "cubic spline curve fit applied to a logit-log transformation," which is a standard statistical method, not AI/ML. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
The device is an in vitro diagnostic (IVD) assay designed to quantitatively determine human prolactin levels in samples, and it does not directly treat or diagnose a disease for therapeutic purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The AquaLite® Prolactin assay is for in vitro diagnostic use."

SaMD (Software as a Medical Device)

The device is an in vitro diagnostic (IVD) kit that includes physical components (polystyrene tubes, antibodies, AquaLite® conjugate) and requires a luminometer for measurement. While it uses software for calculation, it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The AquaLite® Prolactin assay is for in vitro diagnostic use." This is the most direct confirmation.
Purpose: The device is intended for the "quantitative determination of human prolactin levels in sera and plasma." This is a measurement performed on biological samples outside of the body to provide information for diagnosis or monitoring.
Setting: The intended user is "clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
Methodology: The device uses an immunoassay to detect and quantify a specific analyte (prolactin) in a biological sample. This is a common methodology for IVD tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Not Found

Device Description

The washed tubes are placed in a luminometer that is capable of reading a triggered. flash-type reaction in 12 x 75 mm tubes. An injected calcium trigger solution causes AquaLite® to oxide its self-contained luciferin molecule. This reaction produces a twosecond flash of light at 469 nm, which is measured by the luminometer. The intensity of the light is directly proportional to the concentration of the prolactin in the sample. To calculate results, the luminometer uses a cubic spline curve fit applied to a logit-log transformation of the light intensity (in relative light units, RLU) of the prolactin calibrators versus prolactin concentration (in ng/mL).

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

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)

1. Sensitivity: The sensitivity or detection limit of the AquaLite® Prolactin is 0.01 ng/mL. Sensitivity is determined by adding the mean signal of twenty (20) replicates of the zero level calibrator plus two (2) standard deviations above this mean. The prolactin concentration (ng/mL) associated with this calculated signal is defined as the sensitivity of the assay.

2. Specificity: The AquaLite® Prolactin measures intact prolactin. Cross-reactivity was tested for rh FSH, TSH, hCG, hPL, and hGH. Values ranged from Not detectable to 0.52%.

3. High Dose Hook Effect: No high dose hook effect occurs prior to 1,000 ng/mL prolactin.

4. Precision:

(a) Intra-assay precision: Tri-level commercial controls (N = 20 per concentration level) showed % CV of 7.3% (13.6 ng/ml), 7.2% (29.1 ng/ml), and 8.9% (68.7 ng/ml).
(b) Inter-assay precision: Tri-level commercial controls (N = 20) showed % CV of 8.17% (12.8 ng/ml), 8.96% (28.1 ng/ml), and 9.76% (67.8 ng/ml).

5. Method Comparison: The AquaLite® Prolactin was used to assay 100 patient samples against a commercially available automated chemiluminescent immunoassay. A slope of 0.8665 with a y-intercept of -1.9869 was obtained. The correlation coefficient was 0.9669.

6. Linearity and Nonparallelism: Three human serum samples with endogenous prolactin were diluted and assayed. Recovery percentages ranged from 84% to 124%.

7. Spike and Recovery: Five normal male human serum samples were spiked to 25.7 ng/mL prolactin. Percent recovered ranged from 91.5% to 104%.

8. Recovery in Serum and Plasma: Blood samples from 4 normal subjects were analyzed in serum, SST serum, heparin plasma, EDTA plasma, citrate plasma, and oxalate plasma. The data demonstrate no significant differences among serum, SST serum, heparin, EDTA, and citrate plasmas. Oxalate plasma is not recommended.

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

Sensitivity: 0.01 ng/mL
Specificity: Cross-reactivity results
Precision: Intra-assay % CV (7.2-8.9%), Inter-assay % CV (8.17-9.76%)
Method Comparison: Correlation coefficient 0.9669
Recovery: Ranges from 84% to 124%

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.

Chiron Diagnostics ACS 180 Prolactin assay

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

§ 862.1625 Prolactin (lactogen) test system.

(a)
Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.(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

K970188

510(k) SUMMARY

I. GENERAL INFORMATION

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

Common or usual name - Bioluminescent immunoassay (BIA)

Classification name - FDA has classified prolactin test systems intended for the measurement of prolactin in the diagnosis of hypothalamic and pituitary function as Class I devices. 21 C.F.R. §862.1625.

| 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, x227 |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | January 15, 1997 |
| Legally Market Device to Which
Claim Substantial Equivalence: | Chiron Diagnostics ACS 180
Prolactin assay |

II. INDICATIONS FOR USE

ਹ ਅੰ

SeaLite Sciences, Inc.

DEVICE DESCRIPTION III.

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.

IV. SUMMARY OF STUDIES AND TECHNOLOGICAL CHARACTERISTICS

Studies on SeaLite Sciences, Inc. AquaLite® Prolactin were conducted at SeaLite Sciences. The results are summarized below:

Performance Characteristics

1. Sensitivity

The sensitivity or detection limit of the AquaLite® Prolactin is 0.01 ng/mL. Sensitivity is determined by adding the mean signal of twenty (20) replicates of

the zero level calibrator plus two (2) standard deviations above this mean. The prolactin concentration (ng/mL) associated with this calculated signal is defined as the sensitivity of the assay.

2. Specificity

The AquaLite® Prolactin measures intact prolactin. The following human sialoglycoprotein 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 Calibrator A and assayed. Percent cross-reactivity (%) is reported below:

	WHO/NIBSC		Tested
Substance		Lot Number		Value	% Cross-reactivity
rh			2nd I.S. 80/552	1000 ng/mL